Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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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 relating to Process, Facility and Equipment Development at PCI Pharma Services sites. Areas of validation included are:
Process Validation (PV)
Cleaning Validation (CV
Computer Systems Validation (CSV)

Responsibilities

• Ensuring all validation activities on site relating to Facility, Equipment and Processes meet the expectations of clients but more specifically meet regulatory requirements (HPRA/ FDA).
• Comply with Site Validation Master Plan.
• Generate validation protocols for new and existing computer systems, facilities, equipment and processes and review/approve all reports. Also to generate and maintain documentation for cleaning validation performed at PCI sites in Ireland.
• Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions.
• Perform sampling in support of validation studies, including AQL, and cleaning validation.
• Manage tooling validations and associated documentation.
• Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation.
• Support complaint investigations, deviation investigations and change controls as required.
• To undertake such tasks and to manage specific or ad hoc projects as and when required to meet business needs and within the scope of the job-holder’s capabilities.
• Identify and support opportunities for improving processes and or procedures.
• Perform Periodic reviews and revalidations on a scheduled basis.
• Work with Validation team to ensure a robust and compliant validation system is in place.
• Ensure validation being performed is in line with industry standards and latest regulatory guidelines.

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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.

• Ensuring all validation activities on site relating to Facility, Equipment and Processes meet the expectations of clients but more specifically meet regulatory requirements (HPRA/ FDA).
• Comply with Site Validation Master Plan.
• Generate validation protocols for new and existing computer systems, facilities, equipment and processes and review/approve all reports. Also to generate and maintain documentation for cleaning validation performed at PCI sites in Ireland.
• Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions.
• Perform sampling in support of validation studies, including AQL, and cleaning validation.
• Manage tooling validations and associated documentation.
• Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation.
• Support complaint investigations, deviation investigations and change controls as required.
• To undertake such tasks and to manage specific or ad hoc projects as and when required to meet business needs and within the scope of the job-holder’s capabilities.
• Identify and support opportunities for improving processes and or procedures.
• Perform Periodic reviews and revalidations on a scheduled basis.
• Work with Validation team to ensure a robust and compliant validation system is in place.
• Ensure validation being performed is in line with industry standards and latest regulatory guidelines