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.
Main purpose of job:
The role of the Senior Validation Specialist is to implement and execute tasks relating to operational support for product launches, Process, Facility and Equipment Development at PCI Pharma Services sites.
Main responsibilities:
Support the validation effort for all Strategic Projects on site.
Ensure all validation activities on site relating to Facility, Equipment and Processes meet the expectations of clients but more specifically meet regulatory requirements (HPRA/ FDA).
Prepare, review and or approval of qualification and/or validation documentation (VMPs, specifications, protocols, reports etc.) in relation to instrument, equipment, facilities (including cold stores), utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality representation.
Drive solutions, in conjunction with the appropriate department, to ensure customer related validation problems are communicated and corrective actions are in place and closed in a timely manner. Thorough investigation of Quality and Validation issues using Root Cause Analysis methodology and implementation of robust corrective and preventative actions to prevent recurrence. Support change controls as required.
Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions.
Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation.
Supports the coordination & scheduling of packaging validation activities in alignment with planning & packaging functions.
Perform Periodic reviews, revalidations, and continued process verifications on a scheduled basis.
Support all Regulatory Inspections, Customer visits and Customer audits on validation related queries as required.
Must Have:
Min 3 years' Quality experience
Min 2 years' Validation experience
Equipment Qualification (IQ, OQ, PQ) – Hands on experience in protocol generations, execution, completion
Process Validation (PV) experience
New Product Introduction (NPI) - Generation, execution and close out of validation projects
Communication Customer/Internal stake holders/Suppliers
Experience with deviation, CAPA processes
Flexible and able to manage multiple priorities simultaneously
Periodic reviews
Desired:
Experience with packaging - secondary packaging / blister packaging and high speed / automated lines would be a distinctive advantage for this position.
Ability to present risk-based project validation strategy in a clear and concise manner to the Business Unit Planners, Customers and where required, to senior management
Decision Making: Identify and understand issues, problems and opportunities whilst providing a viable solution
Passion for Results: high energy, maturity, ability to work under pressure and deliver results; get things done (an action-oriented approach)
Cleaning Validation (CV)
Computer Systems Validation (CSV)
Temperature mapping
FAT, SAT
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.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
