Validation Specialist

PCI TRGR Penn Pharmaceutical Services Ltd; Killiney; On-site; EUR 42,000 - 62,000; Full time

Job summary

PCI Pharma Services in Stamullen, County Meath, Ireland, seeks a Validation Specialist to implement and execute tasks across Process, Facility and Equipment Validation. The role is permanent and on-site, with duties spanning PV, CV and CSV activities to meet client expectations and regulatory requirements.

The ideal candidate will have a related degree and at least two years’ experience in a GMP or regulated environment, plus strong problem solving, communication and organizational skills.

Qualifications

• Bachelor's or associate degree in Quality / Validation.
• Minimum 2 years’ experience in Manufacturing or Quality.
• Capability to follow clear goals and meet predefined targets.
• Proficient in Microsoft Office products.
• Experience in GMP or Regulated Environments.

Responsibilities

• Ensure safe work practices and report near misses immediately to the EHS Department.
• Ensuring validation activities meet regulatory requirements (HPRA/ FDA).
• Comply with Site Validation Master Plan.
• Generate validation protocols and review/approve reports.
• Maintain documentation for cleaning validation at PCI sites in Ireland.
• Execute validation activities with minimal supervision with other teams.
• Perform sampling in support of validation studies, including AQL.
• Manage tooling validations and associated documentation.
• Support investigations and change controls as required.
• Undertake ad hoc projects to meet business needs.
• Identify opportunities for improving processes and procedures.
• Perform periodic reviews and revalidations.
• Work with Validation team to ensure a robust system.

Skills

Validation

GMP

Quality Assurance

Microsoft Office

Problem Solving

Communication

Flexible shifts

Education

Bachelor's or Associate in Quality/Validation

Tools

Excel

PV

CSV

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 our global network to pioneer and shape the future of PCI. We are looking for a Validation Specialist (Permanent role) to join our team in Stamullen, County Meath. This is a Monday to Friday position, 100% on-site.

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.

• Process Validation (PV)
• Cleaning Validation (CV)
• Computer Systems Validation (CSV)

Key Responsibilities:

• Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department
• 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.
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.

Essential:

• Bachelor's or associate degree or Diploma / Certificate in Quality / Validation. May substitute experience in lieu of educational requirements.
• Minimum 2 years’ experience working in Manufacturing or Quality.
• Demonstrate interest in Validation.
• Capability to follow clear goals, communicate clearly and ensure progress to completion meeting predefined targets.
• Ability to manage multiple tasks and set priorities.
• Problem Solving and Troubleshooting skills.
• The successful candidate should display a dynamic and proactive approach to manage problems.
• Self-motivated with a results driven approach.
• Flexibility to work across different shifts on request in line with business needs.
• Adaptable and ability to work collaboratively.
• Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.).
• Experience in a GMP or Regulated Environment.

Desirable:

• Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.

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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.