Maintenance Technician Day Shift jobs at West Pharma in United States, West Whiteland Township

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.

• In this role, you will serve as a trusted senior HR advisor and partner to the assigned management teams (Global Supply Chain, Global Engineering and West’s Integrated Systems Operating Unit(s)).
• You will be responsible for a wide range of HR activities, including Employee Lifecycle Management, Employee Relations, Training, Culture and Engagement, Performance Management, Compensation, and Benefits, while collaborating with teams such as Compensation, Payroll, and Talent Acquisition as needed.
• The successful candidate will demonstrate strong leadership and communication skills to drive organizational alignment, set priorities, and deliver results. You will also ensure that people strategies (attraction, retention, development, and skills alignment) are aligned with business needs and support effective execution.

• Develop and execute HR solutions for assigned client groups, aligned with West’s mission, vision, and enterprise objectives. Gain a strong understanding of business challenges and human capital needs to actively contribute to strategy development.
• Provide leadership, direction, and expertise on complex matters including performance management, succession planning, employee relations, terminations, culture, recruitment & selection, onboarding, organization design, learning, compensation, employee engagement, and workforce planning:
• Provide guidance and input on restructures, workforce planning, and succession planning.
• Proactively coach, advise, and counsel on performance management issues.
• Monitor employee engagement and help design programs and events that build motivation, retention, and overall talent management.
• Address and resolve complex employee relations concerns, including conducting thorough and objective investigations.
• Serve on committees developing employee programs, processes, and procedures, and support their implementation.
• Partner with Talent Acquisition to attract and retain talent, including approval of offers.
• Leverage HR analytics and technologies to improve efficiency, provide meaningful data for decision-making, and support West’s growth in a dynamic industry.
• Support implementation of compensation programs and annual planning in collaboration with Total Rewards. Advise leaders on compensation-related matters, ensuring alignment with company policies and market competitiveness.
• Collaborate with peers across the US and globally to harmonize HR best practices.
• Participate in and contribute to strategic forums, providing HR data, analytics, and guidance (e.g., annual strategic planning, workforce planning, budgeting processes).
• Maintain awareness of external and internal HR trends and provide strategic solutions that add value to the business.
• Continually assess HR-related business needs and provide proactive, solution-oriented consultation to client groups for both immediate and long-term requirements.
• Serve as a change champion, ensuring effective communication and feedback loops to support smooth transitions.

• Bachelor's Degree in Business Administration, Human Resources or equivalent experience required
• Master's Degree MBA preferred

• Minimum 10 years of relevant HR experience in senior leadership role (strategic and operational) required
• Experience within a global organization preferred

• Strong business acumen and ability to assess HR implications of business priorities
• Proven leadership and collaboration skills to motivate and challenge individuals and teams
• Ability to build, lead, and integrate effective people management programs within a business
• Proficiency in Microsoft Office
• Team player with strong interpersonal and communication skills
• Demonstrated decision-making and problem-solving skills
• High level of professional and ethical standards
• Experience working in international, cross-functional environments
• Expertise in organization development, HR, training, performance management, and talent planning

• Strong written, verbal, and presentation skills, including the ability to make quick, sound decisions
• Excellent organizational skills to plan, prioritize, and achieve goals
• Ability to multi-task, work under time constraints, and problem-solve effectively
• Operates in a professional and sedentary office environment, with routine use of computers and phones
• Must be able to work collaboratively and maintain strong working relationships across the organization

• Human Resources\PHR or SHRM-CP SHRM and or PHR Upon Hire preferred

• Developing and maintaining the strategic roadmap and driving priorities and alignment through strategy deployment
• Serving as a nexus; developing, naturing and acting as partner between the needs of our manufacturing locations, across our manufacturing enterprise to provide the most appropriate digital technology solutions, and resource allocations delivering optimum End to End business
• Responsible for driving Engineering strategies and initiatives
• Responsible for optimizing West Engineering
• Develop and implement and lead a governance model Organization that engages all key stakeholders, makes best use of our internal capability, drives accountability and ensures optimum program prioritization
• Direct, maintain and sustain value of Engineering programs and applications.
• Apply reliability engineering principles to achieve increase uptime and process capability across the network as well as drive creation and implementation of programs
• Optimize plant shutdown initiatives throughout the network and ensure consistency across the sites
• Responsible for Global Maintenance Documentation (Standards, SOPs, Guidelines, best practices) in driving best practices following Good Engineering and Good Manufacturing Practices
• Accountable for monitoring and measuring success and communicating to key stakeholders including site and value stream leadership
• Drive the annual Maintenance Capex budget process along with periodic reviews and measures
• Prepare reports as may be required by ensuring reporting data is accurate and complete
• Manage a team of committed employees and ensure that they execute their tasks in accordance with Safety, Health and Environmental standards. You are responsible for the motivation and management of the team
• Provide technical training and coaching to team members in order to ensure the competence and quality of the maintenance functions
• Collaborate and partner teams to design systems and enabling the tools
• Keeps abreast of new manufacturing use cases, new technologies/solutions and financial supports by building and sustaining collaborative relationships globally with solution providers, Government and state funding bodies and other companies
• Keep current on all relevant technological advancements and developments in the industry, and act as a technical expert
• Other duties as assigned

• Bachelor's Degree with preference Engineering or equivalent technical field experience; Computer Science and/or Information Systems, Manufacturing Automation and Technology required and
• Master's Degree In engineering preferred or
• Equivalent technical field experience preferred

• Minimum 10 years A minimum of 10 years’ experience in Maintenance, Engineering with at least 5 years of global team management; New: A minimum of 10 years of experience in manufacturing, engineering, automation and/or information technology in an automated production manufacturing operations environment required and
• Proven experience in managing cross-functional projects required and
• Demonstrated experience managing difficult engineering challenges and communicating with peers, subordinates and superiors on technical issues required

• Track record of leading teams and building effective working relationships both internally and externally.
• Ability to work with senior leadership teams at manufacturing sites and global headquarters
• Self-starter and independent worker with proficiency in English. An additional language would be a plus
• Proficient with Microsoft Office suite software and project management software
• Advanced working knowledge of maintenance Systems
• 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
• Able to comply with the company’s safety policy at all times • Working knowledge of applicable federal and international regulations such as 21CFR Parts 210, 211 preferred. GLP and GMP experience preferred • Knowledge of Safety standards including CE, OSHA and other similar applicable standards based on regional requirements
• Able to always comply with the company’s quality policy. • The job holder is aware of his/her special responsibility for quality according to the company’s quality policy and conducts his/her activities in accordance with the company quality policy at all times • The job holder respects all specifications arising from the cGMP requirements and from the specifications DIN ISO 15378 and DIN EN ISO 9001 as per its current state and also as it applies to any future amendments
• Expertise in the following Manufacturing capabilities such as SAP, MES, OSI Pi, Connected Worker, Manufacturing Training Platforms, and Advanced Analytics

• Proven ability to work in a virtual environment in a global organization and to effectively prioritize and execute tasks in a high-pressure environment
• Make independent and sound judgments.
• Multitask, work under time constraints, problem solve, and prioritize.
• Excellent communicator with ability to maintain confidentiality and resolve conflicts and ambiguity.
• Read and interpret data, information and documents to analyze and solve problems.
• Learn and apply new information and new skills.

Specialist, Regulatory AffairsWith minimal support, the Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables and ensures compliance with West and government requirements.This position includes leading the direct communication with suppliers and escalation to Category Managers. This role requires understanding and evaluation of impact of US and international regulations/guidelines/policies applicable to all West’s products (elastomers, devices, contract manufacturing, integrated systems) and services.

• Drive material compliance to applicable global product and/or packaging regulatory/environmental legislations (e.g. California Prop 65, RoHS, Conflict Minerals, EU Medical Device Regulation) for all West global product portfolios
• With minimal support, develop compliance process including establishment of user requirements for tools supporting compliance process where applicable
• Lead, monitor and document communication with West’s suppliers requesting supplier documentation and/or questionnaires to support compliance with applicable regulations and customer inquiries
• Assist in development of digitalization and automation processes to improve efficiency in supplier compliance
• Monitor regulations, legislations and policies and provide regulatory guidance and communicate regulatory progress, decisions, strategies to cross functional teams
• Partner cross functionally within the organization (e.g. Procurement, D&T, Supplier QA) to drive efficiency, conformance and compliance
• Provide customers with West product compliance information and data as required for regulatory compliance and submissions to North America, Europe, and Rest of World agencies
• Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures
• Challenge processes, remain open to ideas and changes to continuously improve, seek better alternatives, and drive change
• Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to team and Regulatory Affairs management
• Other duties as assigned

• 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 or
• Advanced degree preferred

• Minimum 5 years Bachelor’s with 5+ years required; or
• Master’s degree/PhD 2+ years medical device regulatory experience required

• Experience interacting with government agencies

• Knowledge of global material compliance regulations

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

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

• Able to work collaboratively across all levels of the organization to influence and persuade others

• Excellent written and verbal communication, timeline management and leadership skills

• Self-motivated with a proactive attitude and the ability to work effectively

• Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures

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

• 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 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 build strong relationships both internally and externally
• Ability to work in a fast-paced environment
• 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).