דרושים Senior Specialist Quality Engineer ב-West Pharma ב-Ireland, Waterford

To ensure quality and technical standards are in place and in use ensuring product and service consistently meets customers’ requirements.
Developing and implementing continuous improvement programs covering production processes and quality management systems.
Analysis of quality problems to identify root causes and implement corrective action to reduce risk of quality failure.

The person will have a strong understanding of the requirements of and the implementation of quality management system and technical standards.
• Review and approval of qualification lifecycle documents for facility & utilities, process equipment and laboratory instrumentation.
• Review and approval of laboratory test results
• Ensuring Data Integrity of laboratory results
• Assist in the investigation and closure of Laboratory investigations, Deviations and Out of specifications
• Communication with External Customers
• Maintenance of validation status of QC and production facilities, equipment, instrumentation and software via review and approval of planned changes and new process introduction.
• Review and approve sampling plans & procedures related to manufacture of products.
• Lead and perform risk assessments and implement control plans.
• Review and approve batch records against approved specifications, quality standards, company procedures and regulatory filings for release of product to market.
• Ensure non conformances/deviations/complaints are investigated and assessed for root cause and identification and closure of effective CAPA’s
• Support quality systems implementations and user acceptance testing where required.
• Lead in Continuous Improvement of Quality processes
• Interact and collaborate with Laboratory; Operations and other functions to support Analytical Laboratory Services and production and timely resolution of issues and investigations.
• Participate in internal audit and Shop Floor audit program
• Maintenance of professional and technical knowledge by attending educational events, reviewing publications, establishing networks and benchmarking.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Perform additional duties as required

• Degree in a Quality, Science or Engineering or equivalent discipline.

  Desired:

  • Quality Auditing certification.
  • Lean/Six Sigma certification.
  • Supervisory experience.

• 5+ years’ previous industrial experience of working as a Quality Engineer or Quality specialist in an ISO13485, EU GMP or 21 CFR Part 210,820 or 211 design or manufacturing environment. Aseptic or sterile manufacturing experience is desired.
• Review and approval of facility, equipment and process validation
• Analytical Method, Equipment/Process and Software Qualification
• Involvement in new product introduction or technical transfer activities.
• Quality planning and communication skills.
• Strong technical writing ability.
• Ability to liaise with customers and suppliers in an informed professional manner.
• Excellent IT, communication and interpersonal skills using current office technologies.
• Ability to work on own initiative, coupled with involvement on cross-functional teams.
• Interest and willingness to learn new skills and take on new tasks
• Strong sense of urgency and flexibility.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target

In this role you will be responsible for performing Supplier Quality activities associated with external suppliers. This role performs activities to ensure West supplier’s maintain compliance with West’s procedures and policies. You will interface with R&D, Sourcing, Design Quality, Regulatory and Operations Quality to drive improved supplier quality performance.

• Establish and successfully executesupplier management planswhich will align to overall business objectives

• Maintain a strong collaborativepartnership

• supplier performanceincluding incoming failures, manufacturing yields and field failures to drive Supplier Corrective Action Reports (SCARs)

• ExecuteSupplier Corrective Action Requests(SCAR) with suppliers, ensuring effective and timely closure

• Work with suppliers, R&D, and Sourcing on continuous improvement of supplier performance includingsupplier changerequest.

• Evaluate potential new or future suppliers and support supplierselection processwith the cross-functional team

• Participate in cross-functional teams of design engineering and quality engineering to work with suppliers duringproduct developmentand ensures agreement for manufacturable, cost-effective designs

• Approves components for use in products by drivingProduct Approvalactivities with the suppliers

• Supports Supplier evaluation,auditmanagement and related records

• Supports the evaluation and development ofQuality Agreements and purchasing specificationswith suppliers

• Support the development of anIncoming Inspection strategyon purchased products

• Bachelor's Degree In Engineering or Science required
• Master's Degree In Engineering or Science preferred

• Minimum 5 years of quality related experience with preferred experience in pharmaceutical and/or medical device industry

• Experience working with suppliers and supplier engagement activities

• Knowledge of sterilization process is preferred

• Knowledge of cGMP, cGDP, relevant ISO standards, medical device requirements and other international regulations

• Familiarity with MasterControl, SAP and working knowledge of statistical data analysis

• Fluent in English

• Thorough understanding of validation activities and risk management principles and techniques

• Strong problem-solving and critical thinking skills

• Negotiation skills and collaborating with suppliers

• Ability to work under high volume production and fast changing environment

• Willingness to work in a cross-functional team with different time zones

• Able to comply with the company’s safety policy at all times.

The Senior Manager, Eng., Facilities and Main will lead and develop a function which supports the needs of operations and other key functions, delivering a best-in-class, cost effective service to the site. Responsible for implementing the plant’s overall preventive and predictive maintenance programs for both equipment and facilities, while maximizing operational uptime and fostering a continuous improvement culture.

• Lead Engineering function for the site. team
• Define and implement comprehensive strategies to reduce costs, mitigate risk, improve quality, shorten downtimes and reduce unplanned interventions.
• Lead and develop the Maintenance and Facilities teams (set objectives, guide and engage the team, train, define development activities, follow-up, provide feedback, prepare appraisal and manage performance and delivery).
• Ensure that maintenance activities are carried out safely, according to company procedures and using relevant permitting systems.
• Provide plant maintenance services to support operations and manufacturing and deliver service and performance in line with company targets & standards.
• Lead and direct maintenance personnel to manage plant & equipment maintenance for reactive and planned works. Deliver preventative maintenance schedule to improve technical availability of assets in line with company targets.
• Build-up an agile team in respect to flexible sift patterns, developing people and training to maximize operational equipment uptime, implement new technologies and apply best practice in maintenance methods and systems.
• Inspect and evaluate physical plant and related equipment in order to manage asset life cycle in support of operations.
• Coordinate with outside contractors to perform service activities, repairs, preventive maintenance on plant and equipment
• Oversee and direct provision of all related maintenance supplies and plant spare parts.
• Lead and foster an environment of continuous improvement for initiatives/projects in the areas of Maintenance and Facilities processes. Providing leadership in supporting the team in identifying and implementing lean, efficiency, cost reduction, quality, and service level improvements
• Manage the team’s performance, conduct performance 1 to 1’s, support recruitment, training and development plans while addressing any issues that arise in a timely manner.
• Responsible for the identification and execution of training requirements and training for the team.
• Maintain a positive employee relations atmosphere. Ensure that there is good communication and co-operation by encouraging knowledge sharing.
• Monitor workload and manage resources in order to support company targets.

• Ensures work and equipment compliance, certification to all related regulatory & statutory directives, standards & guidance’s. Including all necessary regulatory service, permits, permissions, registers & calibrations certifications are controlled & up to date.
• Apply global Engineering standards and processes

• Take a lead role in the introduction and development of maintenance strategies and management systems company-wide.
• Manage and coordinate competing priorities with key stake holders to maximise plant performance and availability.
• Direct the communication of all planned and unplanned works with key stake holders in timely manner. Limiting the impact and reacting responsibly and in prompt and efficient manner.
• Plan and maintain all relevant plant & equipment to ensure that it operates efficiently while delivering this service on time, on budget and in a safe and responsible manner without adverse impact to site performance.
• Deliver to set departmental and site KPI performance levels.
• Serve as a member of the site leadership team and participate in the decision-making process.
• Demonstrates leadership and commitment with respect to the quality management system and with respect to customer focus as outlined in the ISO9001/15378 standards.
• Responsible for ensuring site compliance to ISO17665 standard.

• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct
• Compliance to all local site Environmental, Health and Safety regulations
• Compliance to all local site company policies, procedures and corporate policies
• Other duties as assigned

• Ensure that the validation requirements including CSV, are developed and documented to provide direction for meeting the validation needs of the customers & regulatory bodies.
• Provide guidance to system/process stakeholders for validation life cycle.
• Imbed global technical engineering guidelines to support and standardise facility and equipment engineering and to ensure that best practices are considered for all new project deliverables.
• Keep Site current with the industry standard practices and the various regulatory bodies requirements for validation.
• Oversee and define periodic reviews or re-qualification to maintain validated status of equipment, facilities and utilities as defined by West master plans and SOI’s.
• Responsibility for deliverables for all new engineering projects and contribute to risk assessment of the impact of new and existing systems and their validated state.

• Responsibility for the Management and monthly reporting on site CAPEX forecast and actual spend accuracy.

• Consulting with various global functions for the definition, Design, Execution and start-up of projects which the Waterford site has been selected.
• Ensuring that new installations or facility upgrades follow the correct asset and validation lifecycle.
• Resource planning to ensure projects are delivered in a safe, compliant, timely manner within forecasted budget milestones.

• Bachelor's Degree or equivalent in Electrical/Mechanical/Chemical/Civil Engineering required
• Master’s in Engineering Degree or other related Engineering discipline is an advantage

• 5+ year of experience in a manager or senior manager level role
• 10+ years of experience in a maintenance / engineering role within the manufacturing industry, preferably in rubber, medical device or pharmaceutical operations.

• Good knowledge of LEAN and 6 sigma manufacturing principles
• Experience with continuous improvement of processes and validations of processes/equipment
• cGMP experience
• Self-motivated, results- and solution-oriented personality.
• Ability to combine and apply modern engineering / maintenance and manufacturing concepts to meet engineering goals
• Well-developed communication and interpersonal skills.
• Good organizational and management skills.
• Ability to successfully collaborate with all levels within the organisational.
• Excellent written and communication skills - regularly presents on KPI’s, benchmarking results to all management levels.
• Proficient in planning to maximise resources and reduce expenditure.

In this role, you will perform quality inspection, sampling and quality control testing against approved specifications on incoming, in process and finished products.

• Ensuring all incoming materials, packaging components and returned goods are sampled, inspected, labeled & tested (where applicable) for determining compliance with established specifications and COA/COC.
• Completion of associated documentation and records.
• Generate associated OOS/Deviation/Non-Conformances
• Input of data into the enterprise resource management system.
• Using testing and measuring equipment to conduct inspections.
• Reviews completed production documentation including Worksheets, Batch Cards, logs and any other associated data for correctness/completeness and disposition of in process materials as appropriate.
• Compilation of inspection and testing data to support trending
• Participates in daily production and other scheduled meetings as required
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations.
• Compliance to all local site company policies, procedures and corporate policies.
• Other duties as assigned

• Minimum Leaving certificate required.
• Third level science/engineering qualification is desired.

• Ideally, min 2 years experience in similar role
• Familiarity with SAP/ERP system, SharePoint is desired
• Fluent with Microsoft Office (Word, Excel, Outlook)
• Natural ability to work in team-oriented environment
• Good communication skills
• Attention to detail.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.

In this role you will be responsible for Material Master set ups relevant to Waterford Supply Chain, whilst reviewing and maintaining the site medium- long term horizon planning. Working with cross functional teams you will ensure all master data is accurate and set up in a timely manner ensuring any New Product Introductions are coordinated and tracked from initial set up through to production. You will continually review the level loading of production volumes ensuring all customer orders are scheduled in sequence to meet required shipping dates.

• Set Up Material Master, BOM, Recipe and Shop Floor System for all Finished Goods as per the Promenta process.
• Set up Material Master for SFGs, Raw Materials and Consumables as per the Promenta process.
• Complete New Item Checklists for all new items scheduled for production for the initial production run.
• Maintain alternate production versions of Material Master Data where necessary for envision product
• Ensure Master Data is set up to print customer item number on product labels where required.
• Maintain Recipe Templates for different Process Types – RS, RU, Gamma, RU only etc.
• Proactively liaise with Data Governance and I.T. to solve Master Data issues.
• Maintain and publish relevant KPIs as required
• Create, develop and analyse SAP BI Reports to support key decisions within Supply chain dept.
• Maintain Power BI dashboard - extracting data as per business perspective to improve the business process.
• Ensure Resources are set up correctly. Maintain Pooled Resources where required
• Coordinate a cross-functional team to review, once per year and as a project, all parameters, routings, and standard costs for every SKU.
• Liaise with Data Governance for Mass Upload requests.
• Work with site stakeholders on New Product Implementation tracking the SKUs from set up to production.
• Planning Responsibilities:

• Plan and execute master production schedule – COOISPI, co-ordinating with global planning and plant supply chain to monitor adherence to the plan.
• Lead the planning process for the sheeting area
• Ensure customer orders are scheduled correctly in line with shipping schedule, identify any potential scheduling constraints level loading production as required.
• Review and monitor weekly absorption adherence
• Support printing of batch cards when required

• Update relevant SOIs in relation to the current processes

• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all local site Environmental, Health and Safety regulations.

• Compliance to all local site company policies, procedures and corporate policies.
• Other duties as assigned

• • 3rd Level qualification in Supply Chain, Engineering or similar
  • 5+ years in a similar role ideally within a pharmaceutical or medical device environment.
  • SAP experience required

• Detail orientated and self-motivated.
• Experience in Project coordination
• Ability to prioritize and respond timely to changing requirements, and to coordinate multiple tasks simultaneously and accurately.
• Good organizational, facilitation and excellent communication skills both written and oral required.
• Knowledge of computer software MS office; Word, Excel.

• Program Activities:
  • Responsible for ensuring proprietary design & development projects are executed in compliance with relevant regulations; regulatory requirements; international standards; and enterprise and local procedures.
  • Identify and support the use of improved quality practices by R&D teams during design control activities; and facilitate the smooth integration of quality requirements into design processes.
  • Report on the progress of projects; identify successes; and drive compliance.
  • Escalate quality-related issues to the Design & Quality Assurance Director or designee, as required.
  • Review and approve relevant design history file documents; product drawings; component specifications; labelling; procedures.
  • Support design transfer activities for commercial and launch readiness and sustainment.
• Verification and Validation Activities:
  • Review and approve test method validations (protocols and reports).
  • Review and approve design verification and design / process validation documents (e.g. protocols & technical reports).
  • Facilitate and support the completion of projects up to and including PQ.
• Risk Management Activities:
  • Responsible for authoring and/or reviewing and approving Risk Management Plans, risk assessments and Risk Management Summary Reports for proprietary design & development projects.
  • Facilitate and/or participate in risk assessment meetings with proprietary design & development teams.
• QMS Activities:
  • Support enterprise procedures updates that impact design and development activities.
  • Drive the closure of change controls and protocol non-conformance reports (PNRs).
  • Review and draft relevant procedures and forms for the management of activities connected with product design & development.
  • Act as the interface between development teams and operational quality:
  • Perform first article component and product inspections
  • Draft defect libraries and quality inspection documents during OQ; and manage formal hand over of same to Operational Quality prior to PQ.
  • Support the supplier selection process in accordance with West supplier management procedures.
  • Conduct and support internal and supplier audits, as required.
  • Lead internal audits of R&D and support site QA in the preparation and hosting of third party and customer audits.
  • Lead and manage QMS activities including CAPAs, Failure Investigations, Non-Conformance assessments, audit findings, issue reviews, document control, change controls, and configuration management. Provide direction on non-conformances, deviations, or excursions and drive to closure.
  • Actively engage in robust problem-solving to address quality issues.
• Metrology Activities:
  • Review and approve metrology data during OQ & PQ.
  • Support Quality Function Deployment activities (QFD).
• Compliance to all enterprise and local company policies and procedures.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all site Environmental, Health and Safety requirements, training, and regulations.
• Perform additional duties at the request of the direct supervisor.

• Bachelor'sDegree in Chemistry, Engineering or Quality disciplinerequired

• Must have practical experience working with design teams and providing design assurance support according to international regulatory requirements.
  • Working knowledge of ISO 13485, ISO 9001, ISO 15378 and 21 CFR Part 820 is essential
  • Work experience in the life science industry or another highly regulated, international environment would be considered an advantage
  • Experience in Project Management
  • Experience in process technology, by preference with elastomers.
• Risk Management experience within design and development with good working knowledge of ISO 14971.
• An excellent understanding of rubber and plastic manufacturing technologies, analytical methods and testing.
• Knowledge of analytical tools and methods, including statistics (Minitab preferred).
• Must be able to organise and prioritise tasks.
• Must have critical reading skills, maintain a high attention to detail and overall quality of work.
• Must be self-motivated, able to prioritize and multi-task, work independently and make sound judgements, work under time constraints, thrive in face-paced environments.
• Strong problem-solving skills, including root cause failure analysis methods.
• Must have excellent written and verbal communication skills.

• ISO 13485/9001/15378 Auditor or Lead Auditor Training / Certification upon hire is preferred.

• Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
• Excellent written and oral communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Strong problem-solving skills including root cause failure analysis methods.
• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations.
• Critical reading skills and maintain high attention to detail, accuracy, and overall quality of work.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Ability to make independent and sound judgments.
• Observe and interpret situations, analyze and solve problems.

In this role it is essential to support the day-to-day effective functioning of the site which operates on a 24 X 7 basis. In this role you will lead the Maintenance team/Facility team and be responsible for the planning, scheduling and execution all maintenance/facility activities and projects (including routine maintenance, PM, project, or capital expenditure types of work) to support the facilities or production operations and communicate status with site leadership.

• Ensure the day-to-day operations of the facility or campus, including custodial, life-safety, engineering, site services, and general maintenance, are implemented and carried out in a manner consistent with West policies.
• Work closely and proactively with Operations, Engineering and HSE teams to develop and deploy practices to ensure optimal operation of the site facility infrastructure and minimize impact on the environment.
• Assign, coordinate and supervise activities of the maintenance unit personnel including all plant shutdown related activities.
• Ensure there are sufficient preventive and corrective maintenance procedure in place for safe operation of all infrastructure systems such as electrical, mechanical HVAC and R/O water systems
• Monitor, take immediate action and report on PM related performance.
• Supervise all maintenance programs relating to the interior and exterior conditions and appearance of the property.
• Manage all contracts to ensure they are reviewed on a regular basis and are bid out as required; verify that invoices match contract pricing.
• Hire, train and motivate facility personnel. Maintain positive staff relations. Conduct or approve performance evaluations for staff.
• Coordinate the preparation and publication of the annual budget, quarterly reforecast, and capital budgets for the property.
• Ensure that GMP aspects, current technical standards, local building codes and regulations and safety standards for the buildings are being considered and met.
• Ensure that all site-specific documentation and reports are completed accurately and on time, and other reports and documentation, as required
• Ensure Maintenace back log is maintained and kept at a manageable state. Conduct downtime reviews of equipment failures, implementing activities or
• Other duties as assigned
• Lead the facility management team and supervice facilities support work
• Meeting regulatory and compliance requirements

• Bachelor's Degree or equivalent in Electrical / Mechanical/ Building Service Engineering or Buisness Administration. And required or
• Associate's Degree or Electrical/Mechanical and 5 years or more in leadership position required
• Master's Degree in Building Service Engineering or Business Adminstration preferred

• Minimum of 8 years in Pharma or Med device industry required

• Good understanding of design and construction, operations and maintenance of electrical and mechanical systems and equipment.
• Detailed engineering knowledge of HVAC and utilities with ability to assert technical solutions and standards.
• Strong engineering and trouble shooting skills (facility engineering, electrical systems)
• Detail knowledge of electrical standards.
• Good Interpersonal and Communication skills, Energy conservation knowledge
• Good business acumen and ability to think strategic.
• Strong in Project and Time Management
• Ability to drive change and to think outside the box.
• Excellent communication and leadership skills
• Ability to work under pressure and coordinate numerous activities and groups of people.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Office programs (particularly Word, Excel, and PowerPoint); and must possess good negotiating and conflict resolution skills.
• Knowledge of plant systems and related equipment/utilities as steam, compressed air, vacuum, HVAC, lighting systems, domestic and process water, fire alarm and sprinkler systems, fluid mechanics, dust collection.
• Able to comply with the company’s safety policy at all time
• Able to comply with the company’s quality policy at all times
• Ability to build relationships with stakeholders across muiltiple functions and all levels within and outside the company
• Strong organizational skills that refelct the ability to perform and prioritize multiple tasks seamlessly witj excellent attention to details
• Ability to build relationships with stakeholders across multiple functions within and outside the company