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.
Summary of Role
The role of the Validation Specialist is to implement and execute tasks related to Process, Facility, and Equipment Development at PCI Pharma Services sites.
Areas of validation include:
Process Validation (PV)
Cleaning Validation (CV)
Computer Systems Validation (CSV)
Responsibilities
Ensure all validation activities on site related to Facility, Equipment, and Processes meet client expectations and regulatory requirements (HPRA/FDA).
Comply with Site Validation Master Plan.
Generate validation protocols for new and existing computer systems, facilities, equipment, and processes; review and approve all reports.
Maintain documentation for cleaning validation at PCI sites in Ireland.
Execute validation activities with minimal supervision in collaboration with Technical, Production, and Engineering teams.
Perform sampling to support validation studies, including AQL and cleaning validation.
Manage tooling validations and related documentation.
Ensure strict implementation of validation procedures and accurate completion of validation documentation.
Support complaint investigations, deviation investigations, and change controls as required.
Manage specific or ad hoc projects to meet business needs within capabilities.
Identify and support opportunities for process and procedure improvements.
Perform periodic reviews and revalidations on a scheduled basis.
Work with the Validation team to ensure a compliant and robust validation system.
Ensure validation activities align with industry standards and latest regulatory guidelines.
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Join us and be part of building the bridge between life-changing therapies and patients.
Let's talk about the future.
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer.
We do not unlawfully discriminate based on race, color, religion, age, sex, creed, national origin, ancestry, citizenship, marital or civil union status, familial status, sexual orientation, gender identity or expression, genetics, disability, military status, or veteran status.
At PCI, equity and inclusion are core to our purpose: delivering life-changing therapies.
We are committed to fostering an inclusive workplace, holding ourselves accountable for understanding, fairness, respect, and equal opportunity at every level.
We envision a community where everyone belongs and grows, continually assessing our practices, policies, and culture.
About Us
Why work for PCI Pharma Services?
At PCI, we focus on quality, operational excellence, and delivering an industry-leading customer experience.
Our people are central to this mission.
We aim to create a meaningful and fulfilling environment for talented individuals to develop their careers.
Our culture emphasizes purposeful work, continuous learning, real-life experience, and a fair, competitive rewards program.
We believe in our purpose and approach: our people fuel our business; we find solutions, not excuses.
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