West Pharmaceutical Services

QA Automation Engineer

• Develop new technology and support existing technology to improve production, quality, profitability and safety
• Plan, schedule, and execute projects, communicating project status to targeted timelines
• Manage/assist in facility expansion/modifications
• Ensure technical and customer requirements for assigned projects are achieved
• Develop and maintain required validation and project management documents
• Conduct or participate in routine project reviews with Project Teams and Management
• Perform design work, layouts, sketches, concepts as needed
• Develop and/or review engineering change requests for modifications to processes, equipment and facilities
• Troubleshoot and repair of all automation
• Evaluate and maintain proper machine safeties
• Ensure automation lines are meeting their targeted output and OEE by analyzing production data
• Maintain quality finished product through proper maintenance and operation of all automation
• Provide timely notification to shift leaders and program managers of maintenance and down time issues
• Interfaces daily with engineering manager and shift support staff
• Conforms with regulations, policies, work procedures, instruction, and safety rules
• Performs other duties as assigned by management.

Automation Engineer

Manager

• Ensure safety and security of all colleagues in the Value Stream
• Coordinate production activities to ensure on-time delivery to customers
• Prepare and present operational data including OEE at Tier meetings
• Drive operational improvement projects to deliver competitive advantage

Value Stream Manager

• Disciplinary and technical management of the electrical workshop
• Implementation and execution of modern maintenance strategies
• Further development of the electrical workshop with regard to TPM (Total Productive Maintenance)
• Strategic development of the electrical workshop in areas such as Lean and Six Sigma
• Responsibility for safety and occupational health
• Organization, coordination, and supervision of external contractors

Head of Electrical Workshop – m/f/d

Compliance

• Develop and implement medical device regulatory strategies for administration and safety systems
• Author and review complex product submissions guidance and negotiate submission issues with Agency personnel
• Work with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams
• Prepare US, EU, and other international submissions for new products and product changes
• Work with RA team to build Regulatory strategies for medical device development platform
• Provide leadership to product development teams for regulatory issues and questions
• Provide support to market-released products as necessary

Principal Specialist, Regulatory Affairs

Operations

• Mold and trim products to established specifications in terms of quality and quantity
• Process trimmed product through washing and drying processes
• Ensure accurate setup of equipment
• Ensure continual product flow through the module
• Operate mold press to produce molded panels
• Operate manual/automatic trim press as needed
• Process products through required special treatments
• Setup pack scales for weighing and packing finished product
• Alert Area Supervisor to potential production and quality issues
• Maintain documentation for product traceability
• Inspect molded/trimmed work for quality
• Move materials as required
• Clean and prep workstations/equipment
• Support a Lean environment
• Abide by all corporate and site-specific regulations and safety rules

Production Operator

Producer

• Supervise production processes, schedules and personnel.
• Responsible and accountable for adherence to procedures, proper production, quality, maintenance, safety and schedules on assigned shifts.
• Promote effective employee and company relations to help improve customer service and company profits.
• Maintain close observation of orders to keep informed of manufacturing status and, when needed, initiate the necessary steps to conform to schedule.
• Promote and support site initiatives including safety programs, lean initiatives, training programs, and consistently interpret & apply all policies, practices and procedures among plant employees.
• Recommend and implement measures to motivate employees and to encourage employees to recommend ways to improve process, quality, safety and efficiency.
• Routinely evaluate employee performance and identify training needs.
• Coach and counsel employees for performance, attendance and behavior.
• Participate in the resolution of employee relations issues.
• Review and approve work time in the appropriate time keeping system.
• Maintain and verify accuracy of the hours each employee has worked.
• Adjust direct labor to support demand and manage available resources to ensure on time production and delivery of customer orders.
• Ensure SOPs, cGMP, OSHA and Safety regulations are followed.
• Perform routine visual inspection of work areas for unusual occurrences, safety hazards, housekeeping, work space organization and generate work orders where appropriate.
• Liaise with internal and external customers and other departments as appropriate.
• Participate in special project teams as assigned. Performs other duties as assigned based on business needs.

Associate Production Manager, Finishing

Software Engineer

• Support the engineering team in developing and monitoring low-complexity projects
• Assist in preparing and reviewing technical documents, drawings, and specifications
• Support planning and tracking of project schedules
• Assist with coordination and interface with internal departments (maintenance, production, quality, procurement, etc.)
• Attend field activities and monitor project status updates
• Organize and maintain records, reports, and performance indicators
• Participate in technical meetings and support the preparation of materials
• Contribute suggestions for continuous improvement of departmental processes

Internship – Project Engineering

QA Engineer

• Udføre AQL-inspektioner
• Visuel gennemgang af emner efter gældende specifikationer og kundekrav
• Selvstændig kommunikation af observationer til relevante afdelinger
• Registrering af resultater i SAP og KS
• Udføre kontrolmålinger på kalibreret udstyr
• Bidrage som kvalitetsfaglig sparringspartner
• Supportere ved afvigelser, projekter og reklamationer
• Sikre at instruktioner og AQL-relaterede procedurer afspejler praksis
• Understøtte kvalitetsforbedringer
• Deltage i QA-aktiviteter og sørge for at opgaver dokumenteres korrekt

Tech QC, QA Operations

• The primary responsibilities of the Customer Quality Manager, Integrated Systems, involve over-sight of the Quality Management System (QMS), Customer Quality issues, questions / concerns, Customer facing related items and audits as well as overseeing supplier performance metrics and support / drive supplier audits, out of specification (OOS) investigations.
• Lead and drive internal teams to resolve Out of Spec (OOS) quality issues and be the main point of contact for customers on these issues.
• Partners closely with internal stakeholders i.e Operations, Technical Customer Support, Sales, Labs, R&D, and Product Management to ensure that customer quality issues are resolved in a timely manner and the needs of the customer are being met.
• Maintaining and reporting metrics and trends to Senior Management and Extended Leadership Team (ELT) and implementing improvements on a continuous and pro-active basis.
• Generate, manage and oversee customer and supplier quality agreements.
• Ensuring compliance to corporate, regulatory and customer quality standards will be at the forefront of the responsibilities.

Manager, Quality Assurance – Integrated Systems

Electrical Engineer

• Organize, plan, and execute preventive and corrective electrical maintenance activities in accordance with the relevant SOPs.
• Planning, Project management, as well as the execution and supervision of investment activities.
• Prepares all necessary SOIs for the proper functioning of electrical equipment used in the plant and performs technical supervision of maintenance technicians.
• Supports the Department Manager in daily activities related to the supervision and organization of electrical maintenance and engineering activities.
• Keeps records of performed repairs, modifications, or reconstructions of electrical equipment in the plant.
• Responsible for the technical documentation of electrical equipment in the plant.
• Monitors and ensures compliance with legislation, regulations, and standards related to electrical equipment.
• Plans the necessary spare parts and other technical materials for electrical equipment and creates purchase requisitions.
• Executes all necessary GMP-related validations for manufacturing equipment and facilities.
• Creates reports and analyses of the condition of electrical equipment.
• Participates in investment activities and projects, including execution and supervision.

Engineering Manager

• Responsible for defining, deploying, and scaling automation solutions that improve operational efficiency, quality, safety, and cost performance
• Leads the strategy, design, implementation, and lifecycle management of automated systems
• Partner with operations, engineering, IT, and leadership to identify high-value automation opportunities
• Drive digital transformation across the organization
• Deliver step-change improvements in productivity, throughput, quality, and cost
• Ensure automation technologies are standardized, future-proofed, and aligned to business growth objectives
• Promote and support a Lean Manufacturing environment within the facility
• Provide leadership to engineers and assume responsibility for various engineering projects as assigned
• Facilitate meetings with customers to determine needs, requirements, and customer specifications
• Responsible for project cost accounting and delivering projects on schedule and at budget

• This role supports the Quality Management System and overall quality functions for the West Kearney facility, ensuring compliance with ISO standards and cGMP requirements.
• The position drives quality‑focused continuous improvement initiatives, leads or assists with internal and customer audits, and collaborates directly with customers to investigate and resolve product complaints, including intracompany issues.
• Serving as a key member of the site’s Quality leadership team, this role provides clear communication on quality matters and actively participates in quality steering committees across both corporate and manufacturing environments, helping to align quality strategies and support organizational excellence.
• Contribute to the development and implementation of quality management programs focusing on continual improvement across various processes.
• Assists facility with quality improvement programs by utilizing Six Sigma tools and Lean techniques, including the education of facility personnel on these tools and techniques, as necessary.
• Create processes to better evaluate, track and trend audit outputs and identify risks/issues and evaluate impact on global quality systems and initiate actions, as needed.
• Independently perform supplier audits and corporate facility audit, as required.
• Lead or assist in internal, ISO, customer, and corporate quality system audits.
• Assure execution of internal quality audits, according to established procedures for the assigned areas / locations.
• Provide response to audit observations, and customer complaints and inquiries.
• Lead investigation and coordinate response to customer and intracompany complaints to identify and find the root cause of all product and related quality issues, as well as collaborate with site to determine appropriate corrective and preventive actions.
• Support investigation of out of specifications, non-conformance, and/or deviations as necessary to identify and find the root cause of all product and related quality issues.
• Provide leadership and sound decision-making as member of quality management team.
• Lead meetings with customers, employees and contractors as necessary to manage changes.
• Establish/report monthly KPI’s and metrics to Quality Leadership.
• Fill in for Quality Manager as requested or required.
• Perform other duties as required and/or assigned.

Senior Specialist, Quality Assurance

• The Quality Specialist, Compliance is responsible for maintaining the ongoing compliance of the Quality Management System.
• Responsible for the administration of the Document Management system on site including coordination of all document change request activities for their nominated area of responsibility.
• Provide training and analytical support in the operation of the relevant GMP systems (MasterControl, SAP etc.).
• Responsible for supporting the onboarding of new hires including participation in the Induction Program and Annual GMP Training.
• Perform data analysis and reporting of Quality System Metrics internally and globally.
• Function as Sub Administrator for the site Quality Event Management System to manage and maintain traceable, accountable Quality Records in compliance with Corporate Guidelines.
• Provide Quality document control oversight on documentation and reports.
• Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards.
• Responsible for management of Systems Training – developing, scheduling, and performing.
• Responsible for management of Document Management Training on site – developing, scheduling, and performing.
• Support generation of data for Management Review.
• Management of Site Metrics generation (weekly and monthly) including reporting out Globally.
• Participate in Internal Audit Program.
• Support in the preparation and hosting of Third-Party Audits including audit training and control room set up.

Quality Assurance Specialist

Engineer

• Support design and development activities within West's Product Development Process
• Demonstrate accountability for the successful and timely achievement of goals
• Work independently only with strategic guidance in the most complex situations
• Interpret internal and external business issues and unmet needs
• Define/plan/lead/develop solutions
• Collaborate with local and global functional groups, stakeholders, and management to deliver project goals and meet project milestones
• Plan and execute projects through all phases with a focus on design and qualification through verification and validation
• Write engineering test protocols, reports, and work instructions
• Analyze design of experiments (DOE)
• Drive innovation and process efficiency of integrated systems
• Use sound principles to develop solutions for complex technical problems
• Generate, record and analyze data, and present results to peers and business leadership
• Point of contact for technical product related discussions with the team
• May provide technical expertise and communication for internal and external partners
• Integrate planning activities between West and development/manufacturing partners

Senior Engineer, R&D

Solutions Engineer

• The Sr. Solution Architect, D&T, SAP BW possesses in-depth knowledge and experience to work autonomously
• Responsible for the SAP BW - Development, enhancements, with expertise in Production support
• Act as an expert in leading, designing, implementing and supporting the enterprise BI dashboards and reports
• Work experience in Enhancements and supporting the enterprise BW , expertise in HANA-BW data modelling using Eclipse Tool
• Work with Users and Functional teams to gather & document reporting requirements and to use the underlying data sources/data warehouses to meet business requirements
• Act as an expert in Daily Production support activities pertaining to SAP BW , CDS Views
• Worked on Production support data load issues , bugs , tickets from Business and enhancements
• Expertise in setup table fill concept, extraction from source systems like S4 Hana, ECC, APO
• Worked extensively on extraction from source systems like S4 , APO, HR , Flat file etc
• Expertise in LO Cockpit Extractions, Flat File Extractions and Generic Extractions
• Liaise with the SAP Functional Teams to work on solutioning on all Gaps/Enhancements or bug fixes
• Conduct training programs and knowledge transfer sessions for junior developers as needed