Jobs at West Pharma in Ireland, Dublin

You will be a key strategic partner to our global proprietary business, leading product costing, accounting, and process and system enhancements within the centralized cost accounting COE, supporting West’s Global manufacturing operations across the globe.

We are seeking an experienced leader for this team who has a strong understanding of cost accounting as well as with business process definition, system implementations, and working cross-functionally with the global leadership team. This role is responsible for managing aspects of manufacturing accounting for multiple plants and setting the strategy around costing for the division. This includes developing and monitoring the accuracy of inventory valuation and standard costs in accordance with GAAP requirements as well as month-end financial closing, reconciliations, and reporting.

• Setting strategic goals and long-term objectives within the cost accounting team
• Developing and maintaining policies and procedures within the cost and inventory accounting function and drive consistency and standardization within the wider cost accounting team
• Drive value in West through collaboration with senior leaders to align departmental strategies with organizational goals, and ensure execution on these strategies
• People:• Own inventory valuation and product costing processes within scope of role
• Lead SAP implementation for the FICO module as it relates to plant accounting, product costing, and associated master data as plants transition manufacturing to S4
• Oversee the plant level month end close tasks including the preparation of journal entries, reserve and variance analyses, and account reconciliations for all manufacturing locations supported by the wider cost accounting team
• Responsible for coordinating all the details to develop the annual standard costs in collaboration with FP&A, Supply Chain Planning and Operations
• Ensure appropriate controls and compliance with US GAAP
• Support and assist in the global initiatives relating to cost accounting for all regions/divisions of West
• Support and assist other functions within the business as required

• Bachelor's Degree required

• Minimum 10 years within Cost Accounting with
• Minimum 10 years of post-qualification experience in a manufacturing industry required
• Minimum 5 years of relevant experience as leading the Finance function of a company required

• Extensive knowledge of SAP
• Understanding of the manufacturing environment and the associated financial processes
• Knowledge of supply chain, receiving, inventory flow, operations process and manufacturing principles
• Strong ability to assess problem situations to identify causes, gather and process relevant information, generate possible solutions, and make recommendations and/or resolve the problem
• Ability to effectively analyze transactional level detail in an enterprise resource planning system and articulate the key findings to senior management
• Ability to multi-task and drive actions to completion under strict deadlines
• Understanding of GAAP and internal control principles
• High proficiency in Microsoft Excel

• MBA, CPA, or CMA
• Prior SAP implementation experience

Manages the maintenance and repair of equipment and facilities in operation. Liaises with external contractors for the maintenance and repair of same. The Facilities Maintenance Technician is also responsible for running and maintaining the preventative maintenance system to pre-determined guidelines. Reporting directly to the Facilities Manager.

• Responsible for the maintenance of plant and equipment in the facilities department, compiling standard specifications /procedures for each item and monitoring all existing plant to standard specifications.
• The above equipment will include AHU’s, chillers, compressors, dryers and electrical systems.
• Responsible for specifying and purchasing the most suitable equipment spares and in conjunction with the procurement department negotiating the best deal.
• Establishes relationships with the customers and suppliers in pursuit of continuous improvement and on-going business development.
• Attends internal meetings to help establish priorities and assign tasks.
• Solves, in conjunction with the Quality department, customer related problems/issues as needed.
• Ensures works and related work-orders are processed in full via SAP.
• In conjunction with approved vendors, research new processes and/or systems for maintenance/manufacture of equipment and implement new processes and systems as developed under the direction of the Operations Manager.
• Coordinate the development of documentation in the facilities areas in line with ISO9001, ISO 13485, ISO 14001 requirements, and review the systems with appropriate personnel and the Quality department on a regular basis to ensure conformance to same.
• Compliance to all site Environmental, Health and Safety requirements, training and regulations.

Time served Electrician - Advanced level 6 trade certificate qualification.

• A minimum of 3+ years post experience within a high-volume manufacturing environment would be an advantage.

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• Ability to read electrical and hydraulic/pneumatic schematic diagrams - Essential.
• Previous experience in CMMS with ability to navigate competently.
• Previous experience working on technically challenging applications would be an advantage (i.e.) medical, Pharma, tight tolerance work.
• Experience of working in a GMP environment - clean rooms, MALs, PALs, gown-ups, labs, plenums related to equipment servicing such.
• Ability to interact with suppliers, customers and external contractors.
• Previous experience in facilities maintenance would be a great advantage.

• Must be able to work in a fast-paced environment.
• Must be able to organize and prioritize tasks; must be detail orientated and self-motivated.
• Must be able to deal with all levels of employees and work across various departments.
• Must be able to work independently on own projects while working concurrently with all departments.
• Establishes relationships with the customers and Equipment/ Raw Material suppliers in pursuit of continuous improvement and on-going business development.

Reporting to the Toolroom Supervisor, the Toolmaker will be responsible for the maintenance and repair of all moulds in operation at West. This role involves working closely with Toolroom Leads and Production Supervisors to understand daily priorities and ensure resolution to tooling issues in a timely manner.

• Responsible for the repair and maintenance of moulds including investigations and root cause analysis of major tooling issues.
• Responsible for the manufacture of jigs & fixtures, in the support of mould and equipment maintenance.
• Gathers critical tooling information for report composition.
• Identifies continuous tooling improvements for future/repeat moulds.
• Reports/escalates all issues to Toolroom Supervisor.
• Assists the Toolroom Supervisor in the development of tooling documentation and the compiling of maintenance procedures for each mould.
• Works with Production Supervisors in troubleshooting mould issues.
• Solves, in conjunction with the Quality Department, customer related issues as required.
• Attends internal meetings to establish priorities.
• Liaises with external suppliers on the repair/replacement of tooling components and equipment.
• Assists the Toolroom Supervisor in the identification and development of talent within the team and delivering training as required to new employees and apprentices.
• Provides direct supervision to Apprentice Toolmakers during their apprenticeship.
• Responsible for the capture of all tooling intervention information and data on SAP PM.
• Proposes improvements to processes and procedures to Toolroom Lead and Supervisor.
• Works autonomously within established procedures and practices.
• Supports and contributes in Lean Six Sigma projects.
• Complies to all site Environmental, Health and Safety requirements, training and regulations.
• Complies to all local site company policies, procedures and corporate policies.
• Acts in accordance with West’s Guiding Principles and adheres to the Corporate Code of Conduct.
• Perform additional duties at the request of the direct supervisor.

• Toolmaking qualification with minimum 3 years’ experience, ideally with time served producing injection moulds.
• Excellent machining knowledge and skills.
• Previous experience in a mould maintenance environment supporting high volume manufacturing.

• Toolmaker qualification

• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.
• Strong written and verbal communication skills.
• Good understanding of the injection moulding process.
• Experience in maintaining hot runner systems.
• Knowledge of SAP PM module.
• Ability to weld.
• Knowledge of tooling hydraulics, pneumatics and electrics
• Proficient IT skills, specifically Microsoft Office (Word, Excel, PowerPoint and Outlook).
• Experience in 3D modelling and drawing software packages (e.g. SolidWorks).

• Must be able to stand/walk for periods of up to 4 hours between rest periods.
• Must be able to lift equipment and tools up to 25kg up to 10 times per day.
• Must be able to climb up and down stepladders/stairs up to 10 times per day.

Mental:

• Ability to reason logically and make sound decisions, to consider alternative and diverse perspectives and to communicate effectively both orally and in writing.
• Ability to simultaneously address multiple complex problems.
• Ability to work as an integral part of a team.
• Ability to work under pressure.
• Ability to understand, remember and follow verbal and written instructions.
• Ability to complete assigned tasks without direct supervision.

When absent from the site duties and responsibilities will be delegated to the following designates:

Toolroom Lead

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

• Bachelor’s degree in engineering or related science

• 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.

• Fostering high performance culture, focused on efficiency, accountability, collaboration, and continuous improvement
• Supporting all inflowing requests for customer related documents globally
• Managing orders accurately End to End for standard orders, samples, lab orders for proprietary business and contract manufacturing in the relevant ERP system
• Issuing Quotations, Order acknowledgements, Returns, Credit and Debit notes; DA‘s, notifications
• Verifying orders which come in through the OCR queue or webstore
• Taking care of Export and Import handling as well as pricing related activities,
• Initiating new customers through data creation, triggering Item creation
• Updating customer master data and information records through SAP as well as providing copies of certifications, documents etc. for customers.
• Handling Document Control, CMIR incl. Shipping instructions
• Internal stakeholder relationship management (SCM/Ops/Quality/Shared Services)
• Liaising with plants and wider supply chain to identify best way forward in case the customer requested dates cannot be met
• Cooperation with the customer experience unit supporting internal audit findings and projects for continuous improvement
• Other duties as assigned

• High School Diploma GED or equivalent required
• Minimum 3 years in client services or customer service required

• Knowledge or experience with ERP tools like SAP with Sales and Distribution
• Working knowledge of MS Office or the willingness to learn it quickly
• Highly proficient in written and spoken English and one further language of our business areas
• Strong communication skills
• Strong people skills – approachable, good listener, empathetic
• Strong learning capacity
• Ability to work independently in global environment
• Understanding of Incoterms and Export/Commercial Documentation Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety and quality policies at all times

• Communication, quick decision making, interpreting data, reading or writing, must be able to express or exchange ideas with team members
• Must be able to understand direction and adhere to established procedures

• High School Diploma Technical certificate in Precision Machining/Mechanical Engineering required

• No min required

The Regulatory Affairs Sr. Specialist is responsible for post market activities for medical devices, supporting department regulatory processes and procedures, supporting strategies, authoring, reviewing, and supporting global registrations. The Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables. In addition, the Sr. Specialist mentors team members and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This position includes supporting internal and external customer regulatory requests.

• Support regulatory strategies for OUS medical devices and combination products, ensuring compliance with global guidelines, evolving regulations and industry standards.
• Author regulatory documentation such as CIAs, Technical Documents, PMS Plans, PSURs, PMCF and vigilance reports and field safety corrective actions to Notified Bodies, EMA, and other global competent authorities.
• Complete global Post Market Surveillance (PMS) activities and assignments for OUS medical devices and combination products in West’s portfolio.
• Support West’s medical device EU importation requirements as Importer in accordance with Article 13 of MDR.
• Provide technical review of data and reports supporting regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation are fit for purpose.
• Collaborate with cross-functional teams and external stakeholders to provide guidance, issue resolution, responses to inquiries, and actions taken.
• Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to RA management, internal and external customers.
• Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals.
• Adhere to all applicable government requirements and West practices, and procedures to maintain compliance.
• Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required.

• Bachelor's Degree in science, math, engineering, or related discipline required or
• Master's Degree in science, math, engineering, or related discipline preferred or
• PhD in science, math, engineering, or related discipline preferred

• Experience: Bachelors with +5 years or master’s degree/PhD with 3+ years of medical device regulatory experience
• Experience with EU MDD (93/42/EEC), EU MDR (2017/745), MDCG guidance, ISO 13485 and US FDA regulations (Title 21CFR820), ISO 14971, and ISO 14155, EU combination product regulations (e.g., EMA/CHMP/QWP/BWP/259165/2019)
• Experience in preparation of dossiers for submission to competent authorities including supporting design and development of medical devices and combination products over the product lifecycle
• Strong decision-making, communication, and technical writing skills
• Ability to work independently and manage multiple priorities and ability to triage and manage work priorities and to follow established processes while identifying areas for process improvement in a changing environment

• Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred

• Established scientific and quality expertise with criteria described above
• Experience in direct engagement with regulatory authorities
• Regulatory compliance competency in Quality Management Systems
• Knowledge of US FDA regulations and submission pathways (e.g., 510(k), DMF, MAF, BLA)
• Familiarity with US drug-device and ROW combination product requirements
• Advanced degree and/or RAC certification

• Ability to work in sedentary environment, in an office; may need to stand or sit for extended periods of time.
• Ability to comprehend principles of math, science, engineering, and medical device use. Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
• Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
• Ability to review, collate, describe, and summarize scientific and technical data. Ability to organize complex information and combine pieces of information to form general rules or conclusions.
• Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
• Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
• Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams.
• Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures.
• Ability to build strong relationships both internally and externally.
• Ability to work in a fast-paced environment.
• Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.
• Ability to verbally communicate ideas and issues effectively to other team members and management.
• Ability to write and record data and information as required by procedures.
• Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).