Sr. Validation Specialist

PCI Pharma Services; Stamullen; On-site; EUR 50,000 - 70,000; Full time

Job summary

PCI Pharma Services in Stamullen, Ireland is hiring a Senior Validation Specialist. This role is pivotal in implementing and executing tasks for operational support on product launches, as well as in Process, Facility, and Equipment Development.

Applicants should have a minimum of 3 years of Quality experience and 2 years of Validation experience, specifically in protocol generation and execution. This position offers a chance to contribute significantly to validation efforts aligned with regulatory requirements.

Qualifications

• Minimum 3 years of Quality experience.
• Minimum 2 years of Validation experience.
• Hands-on experience in protocol generation, execution and completion.

Responsibilities

• Support validation effort for all Strategic Projects on site.
• Prepare, review and approve validation documentation.
• Drive solutions to ensure validation problems are addressed.

Skills

Quality experience

Validation experience

Communication with customers

Ability to manage multiple priorities

Decision making

Tools

Deviation and CAPA processes

Equipment Qualification (IQ, OQ, PQ)

Process Validation (PV)

Job description

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 the 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 and regulatory requirements (HPRA/FDA).
• Prepare, review and approve qualification and/or validation documentation (VMPs, specifications, protocols, reports, etc.) concerning instruments, equipment, facilities (including cold stores), utilities, automated systems, manufacturing processes and cleaning processes, including FAT, SAT, IQ, OQ and 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. Conduct thorough investigations of Quality and Validation issues using Root Cause Analysis methodology and implement 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 strict implementation of validation procedures and timely, accurate completion of all validation documentation.
• Support coordination and scheduling of packaging validation activities aligned with planning and 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

• Minimum 3 years of Quality experience
• Minimum 2 years of Validation experience
• Equipment Qualification (IQ, OQ, PQ) – hands‑on experience in protocol generation, execution and completion
• Process Validation (PV) experience
• New Product Introduction (NPI) – generation, execution and close‑out of validation projects
• Communication with customers, internal stakeholders and suppliers
• Experience with deviation and CAPA processes
• Flexibility to manage multiple priorities simultaneously
• Periodic reviews

Desired

• Experience with packaging – secondary packaging/blister packaging and high‑speed/automated lines is a distinctive advantage for this position.
• Ability to present a risk‑based project validation strategy clearly and concisely to Business Unit Planners, Customers and, where required, to senior management
• Decision making: identify and understand issues, problems and opportunities while providing viable solutions
• Passion for results: high energy, maturity, ability to work under pressure and deliver results; 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.