PCI TRGR Penn Pharmaceutical Services Ltd
Location
Northern Ireland | United Kingdom
Job description
Commissioning and Qualification Lead, Validation page is loaded
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Leading and managing all aspects of validation engineering within PCI’s commissioning and qualification of equipment and processes for critical projects.
· Ownership and accountability for the progress and status updates of large-scale validation projects.
· Representation of project status, risks, and concerns to stakeholders and customers from a validation/quality perspective.
· Ensuring delivery of projects with an emphasis on quality from design to validation, focusing on Right First Time (RFT) and On Time In Full (OTIF) principles.
· Introducing new, compliant, and efficient equipment; including drafting User Requirement Specifications (URS), Functional Specifications (FS), Design review documentation, software, and hardware specifications (SDS and HDS), Standard Operating Procedures (SOPs), change controls, factory acceptance test (FAT), site acceptance test (SAT) protocols and reports, Validation Project Plan (VPP), Validation Summary Report (VSR), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and Process Validation (PV) protocols and reports. All other validation and quality documentation as required.
· Mentoring junior staff and supporting the onboarding of new team members.
· Planning and executing Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT), coordinating with cross-functional teams.
· Ensuring timely completion of technical documentation in support of project schedules for new equipment introductions.
· Working cross-functionally to define line layouts using Good Engineering Practice (GEP).
· Supporting risk management processes, including risk assessment for new or modified equipment and processes.
· Acting as author, reviewer and approver on behalf of the validation department in the Validation process for new equipment introductions and NPI.
· Assisting in technical, product, and process reviews in conjunction with Operations to resolve issues.
· Ensuring all activities comply with statutory, regulatory, and company EHS, cGMP, and technical standards and procedures.
· Promoting and sustaining a working environment aligned with PCI Pharma Services
Values and Behaviours.
· Collaborating across PCI Pharma Services to drive performance and consistency across sites.
· Managing specific or ad hoc projects / tasks as required to meet department and business needs.
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.
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