West Pharmaceutical Services · 1 day ago
Principal Process Validation Engineer
US Pennsylvania Jersey Shore
Full-time
Hybrid
Lead/Staff
8+ years expWest Pharmaceutical Services is dedicated to improving patient lives and has a long history in the healthcare industry. The Principal Process Validation Engineer will be responsible for developing and implementing validation engineering strategies to ensure compliance with GMP guidelines, while leading validation efforts for strategic projects.
BiotechnologyHealth CareIndustrialManufacturingPackaging ServicesPharmaceutical
Responsibilities
Lead the validation effort for all Strategic Projects on site
Lead the preparation, review, and approval of the Site Validation Master Plan
Develop Validation Plans to support Site Validation Master Plan
Site subject matter expert on Cleaning Validation, Process Validation, Equipment Validation, Computer System Validation, Data Integrity and Facility Qualification
Preparation, review and or approval of qualification and/or validation documentation (specifications, protocols, reports etc.) in relation to instrument, equipment, facilities, utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality representation
Review and approval of third party generated protocols and reports in conjunction with program Quality representation
Fosters and encourages shared learning’s across the organisation e.g. system and technology best practices
Chair, schedule and minute validation meetings and participate in meetings when required
Preparation, review, and approval of standard operating procedures and policies
Perform periodic reviews of systems in order to maintain validation status
Support the set-up and maintenance of electronic validation documentation while ensuring the archiving and filing of hard copy validation documentation across all projects
Develop and implement site validation strategy to meet customer and West needs
Work with all departments across the business to ensure that new processes meet their requirements
Represent West at customer meetings to ensure that the needs of the business are met
Assist with the training and development of personnel at all levels of West on new processes or systems introduced to the company
Ensure that the procedures and systems are in place to facilitate the introduction of new processes and equipment
Lead and manage a high performing team to deliver the defined business goals and objectives
Other duties as assigned
He/She is authorized to make a decision to stop work in the plant in accordance with official procedure of West Pharmaceutical services, in cases of huge material damages and/or employees being in jeopardy, especially in absence of Production manager
He/She is authorized to approve entrance of third parties into the plant, in accordance with official procedure of West Pharmaceutical services
Qualification
Required
Bachelor's Degree Must have a third level qualification, at a minimum to degree level, in Computer Science, Engineering or related fields or equivalent experience required
Minimum 8 years of validation engineer experience in a cGMP regulated industry, and experience of working in a high-volume manufacturing environment ideally in the Medical Device / Pharmaceutical sector
Preferred
Must have in-depth / working knowledge of: ISO 13485; EU GMP, CFR Part 820
An excellent understanding of plastic process manufacturing, computer validation, analytical methods and testing and documentation systems is desired
Must have dealt with customers in a previous employment
Must have excellent written and verbal communication skills as well as the ability to accurately document work performed
Demonstrated ability to lead, influence and train others
Must be able to work in a fast paced environment
Must be able to travel as required by the position
Must be able to organize and prioritize tasks; must be detail orientated and self-motivated
An ability to collaborate across functional teams and work effectively in a matrixed team environment
Must be able to work independently on own projects while working concurrently with all departments
Support and contribute in Lean Sigma programs and activities towards delivery of the set target
Able to comply with the company's safety and quality policies at all times
Benefits
Benefit programs
Health Insurance
Company
West Pharmaceutical Services
West Pharmaceutical Services is a manufacturer of technologically advanced containment and delivery systems for injectable medicines.
5001-10000 employees
H1B Sponsorship
West Pharmaceutical Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (24)
2023 (18)
2022 (26)
2021 (17)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO
Leadership Team
Eric Green
Chairman, President, and CEO
Atul Patel
Vice President, Devices & Delivery Systems
Recent News
2026-01-20
Company data provided by crunchbase