West Pharmaceutical Services

Solutions Engineer

• Handle various computer system validation activities for different cross functional programs across West Pharma.
• Lead and execute validation activities for GxP computerized systems in compliance with global regulatory requirements (FDA, EU Annex 11, GAMP 5, CSA).
• Author, review, and execute validation deliverables (VP, URS, RA, IQ/OQ/PQ, RTM, VSR).
• Guide cross-functional teams (QA, IT, Engineering, Manufacturing, Vendors) to ensure validation requirements are properly integrated during system implementation and changes.
• Participate in internal audits and regulatory inspections, providing validation rationale and documentation support.

Solution Architect – Validation & Testing

Auditor

• Perform sampling, inspections, and testing of in-process and finished goods products per applicable procedures and AQL plans
• Release acceptable in-process and finished goods product for further processing and/or shipping as applicable per site
• Understand and follow applicable ISO standards requirements
• Perform review of inspection records to assure product conforms to specifications and proper documentation practices
• Retains sample of finished products and maintains all applicable documents to form batch records
• Ensure appropriate batch records disposition (i.e. filing, scanning etc.) as necessary
• Print documents from Master Control, shopfloor or other software program and manages documents related to the Quality System
• Segregate nonconforming product and handle quarantined product and raw materials as applicable by site
• Generate rejection and deviation reports as directed by site
• Perform trace back investigation of nonconforming raw material and product as directed by site
• Promote and support a Lean environment
• Conform with and abide by all corporate and site-specific regulations, policies, work procedures, instruction, and all safety rules

Molding Quality Auditor

Software Engineer

• Responsible for maintaining operation efficiency of automated assembly lines.
• Provide support to shift operations as requested by the shift leader/production manager.
• Logically troubleshoots and repairs the pilot assembly line and related bench top equipment.
• Assists shift lead in maintaining quality of finished product through proper machine operation.
• Responsible for maintaining spare parts inventory with proper cataloging of parts.
• Reviews line history and documentation to enhance line efficiencies.
• Follows escalation plan to minimize downtime.

Engineering Technician

Engineering Manager

• Responsible for overseeing Automation, Processing, and Tooling functions within the site
• Provide strategic and technical leadership across critical manufacturing technologies
• Oversee cross-functional engineering teams that design, optimize, and support automated equipment
• Act as a key partner to Operations, Quality, and Supply Chain
• Build and sustain a high-performing engineering organization
• Grow and develop engineering leadership through mentorship and coaching
• Plan and execute long term strategies to align with business objectives
• Understand and drive improvements to engineering KPIs
• Manage several engineering groups with direct reports
• Develop and execute process enhancements

Senior Engineering Manager

• Perform a variety of tasks and conduct test procedures regarding the quality process
• Ensure that the pre-determined high standards of quality are achieved and maintained
• Review and approval of metrology reports for batch release and validation purposes
• New product validation, analysis and reporting
• Quality support to Engineering and Production Departments
• Establish and maintain documentation in line with West Williamsport and West Pharmaceutical Services Quality Systems
• Liaise with customers and suppliers on new and existing projects
• Ensure that all parts/materials conform to all requirements and applicable drawings and specifications
• Maintain good communications both internally and externally
• Ensure that all metrology equipment is correctly calibrated
• Assist shift personnel with quality issues and/or measurement techniques
• Perform periodic audits as requested and complete necessary documentation
• Archives quality records, samples and log procedures
• Batch paperwork review and final decision to release product for shipment
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct
• Compliance with all Environmental, Health and Safety requirements, training and regulations

Quality Auditor

Human Resources

• Maintenance of personnel files, including document filing
• Tracking of pre-employment medical checks and filing related documents
• Follow-up on probation-period documents and job descriptions
• Sending standardized BEM invitations and reminders
• Assisting with scheduling of BEM meetings
• Processing employment references and certificates

Student Assistant – Human Resources

Engineer

• The Maintenance Engineer (m/f/d) plays a critical role in ensuring that production and utility systems are operated safely, efficiently, and reliably.
• This position is responsible for developing and implementing asset criticality and reliability strategies, optimizing maintenance plans, and leading root cause analyses to minimize downtime and improve overall equipment availability.
• The Maintenance Engineer analyzes equipment performance data, drives preventive and predictive maintenance programs, and works closely with Operations, Safety, Quality, and Engineering to ensure compliant, high-performing, and reliable production systems.

Senior Maintenance Engineer – m/f/d

• Maintenance of personnel files, including uploading documents
• Tracking pre-employment medical examinations and uploading related documentation to the e-file
• Monitoring probationary period documentation and job descriptions
• Sending standardized BEM invitations and reminders
• Supporting the scheduling and coordination of BEM meetings
• Preparation and processing of employment reference letters

Working Student – Human Resources

• Provide HR support services for the business in an efficient, effective and timely manner.
• Consults with managers and supervisors regarding employee performance issues and assists with the disciplinary process.
• Ensure consistency with regard to application of rules and regulations.
• Build and maintain effective working relationships with partners, suppliers, service vendors, employees and internal and external customers.
• Manage HR paperwork and systems including new hires, transfers, attendance tracking, pay, badging, termination, filing, postings and announcements.
• Evaluate the effectiveness of current HR programs and recommend changes.

Senior HR Specialist

Manager

• Oversee a team of Material planners
• Take overall responsibility for Service metrics including OTIF(P) and Lead times to customers
• Manage inventory metrics including Days of Supply/Inventory Turns
• Take ownership of material planning issues
• Lead daily meetings to address potential late customer orders
• Create and implement production plans for high value processes
• Ensure production plans align with customer ship dates
• Design and implement capacity utilization models
• Act as liaison between Planning, manufacturing and customer success
• Ensure strategic and operational information is available to share
• Manage, coach and develop a high performing team
• Monitor production performance vs. plant and division goals

Planning Manager

Operations

• Raw material/final product release
• Incoming control and release of raw materials based on tests and documentation
• Review batch documentation and release finished products
• Participate in internal and customer audits (in English)
• Prepare and maintain local instructions within the area of responsibility AQL and product control
• Perform visual inspection of products according to applicable specifications and customer requirements
• Carry out control measurements on products
• Register results in SAP
• Ensure that instructions and AQL procedures reflect current practices

Quality Operations Assistant

Project Manager

• Lead cross-functional regulatory project teams in the development and execution of global regulatory strategies
• Drive end-to-end regulatory project execution for high-impact programs
• Direct the preparation and submission of complex regulatory dossiers
• Ensure submissions meet quality standards and regulatory expectations
• Lead interactions with external customers, partners and regulatory agencies
• Drive continuous improvement initiatives within the regulatory function

Principal Regulatory Affairs Project Manager, Medical Devices

• Provide HR business partner support across all assigned business clients within designated location.
• Support the implementation of global human resource initiatives under the direction of the HR leadership team.
• Provide the appropriate HR support in the acquisition, development and retention of talent, working in close collaboration with talent acquisition teams; including background checks, scheduling interviews, greeting candidates upon arrival, new-hire onboarding, etc.
• Provide HR clarification around benefits, payroll, HR policies and practices to employees.
• Enter employee information into the HRIS system for processing (i.e., new hires, terminations, promotions, leave of absences, etc.).
• Support HR in performance management cycles within the West Talent Gateway system, including gathering data and sending emails to ensure compliance.
• Site administrator back up for Learning Management System including scheduling online learning classes, tracking attendance and maintaining files.
• Serve as HR liaison between the local and global HR functions depending on business issues.
• Ensure that consistent practices are maintained between HR and the business.
• Actively participate in HR forums to further progress the organization’s HR value proposition.
• Consults with managers and supervisors regarding employee performance issues and assists with the disciplinary process by helping conduct employee termination discussions and mediating and assisting in solving employee performance and/or work issues.
• Collaborating with managers and Corporate HR Compensation on job reclassifications and writing job descriptions.
• Conducting workplace investigations, including cases related to discrimination and sexual harassment, and escalates to HR Manager and Plant Manager.
• Workplace planning to include assisting with identifying personnel and training needs.
• Uses data, statistics, evidence-based research, benchmarks, HR and business metrics to facilitate decision-making.
• Participate in weekly plant GEMBA walks, be visible and accessible to all team members.
• Other duties as assigned.

HR Business Partner

• Perform sampling, inspections, and testing of in-process and finished goods products per applicable procedures and AQL plans.
• Release acceptable in-process and finished goods product for further processing and/or shipping as applicable per site.
• Understand and follow applicable ISO standards requirements.
• Perform review of inspection records to assure product conforms to specifications and proper documentation practices.
• Retains sample of finished products and maintains all applicable documents to form batch records.
• Print documents from Master Control, shopfloor or other software program and manages documents related to the Quality System.
• Segregate nonconforming product and handle quarantined product and raw materials as applicable by site.
• Generate rejection and deviation reports as directed by site.
• Promotes and supports a Lean environment.

Quality Auditor – Assembly

• Take responsibility for a well-defined process area and process related projects
• Initiate, lead and coordinate continuous process improvement on quality, service, HSE and cost
• Provide expertise in Compounding technologies relevant for West products
• Support the introduction, start-up and validation of new equipment in the plants
• Lead workstreams to implement / roll-out new innovative processes and technologies