Validation Specialist

About PCI Pharma Services

PCI Pharma Services is dedicated to delivering life-changing therapies worldwide by partnering with numerous biopharma organizations and their patients. Our core investment lies in our people who foster meaningful impact, push innovation forward, and build a better future. We aim to assemble dedicated teams throughout our global operations to drive the advancement of PCI’s mission.

Role Summary

We invite applications for a permanent Validation Specialist to join our team at Stamullen, County Meath. This full-time, Monday-to-Friday role requires 100% onsite presence. The Validation Specialist will focus on planning and executing validation tasks related to processes, facilities, and equipment across PCI Pharma Services sites.

Validation Areas

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

Key Responsibilities

• Maintain adherence to safe working practices and report all near misses promptly to the Environmental Health and Safety (EHS) Department.
• Ensure all validation activities involving facilities, equipment, and processes align with client requirements and comply with regulatory standards, including HPRA and FDA guidelines.
• Adhere strictly to the Site Validation Master Plan.
• Develop validation protocols and review/approve reports for new and existing computer systems, facilities, equipment, and processes. Maintain cleaning validation documentation for PCI sites across Ireland.
• Carry out validation tasks independently, coordinating with Technical, Production, and Engineering teams as necessary.
• Conduct sampling for validation studies, including AQL and cleaning validations.
• Oversee tooling validation processes and related documentation.
• Ensure full compliance with validation procedures and timely completion of all validation documents.
• Assist with investigations related to complaints, deviations, and change controls.
• Manage special projects or assignments as needed within the scope of the role.
• Identify and recommend opportunities for process and procedural improvements.
• Perform scheduled periodic reviews and revalidations.
• Collaborate with the Validation team to maintain a robust and compliant validation system.
• Ensure validation activities meet current industry standards and regulatory expectations.
• Execute additional duties as assigned in line with company objectives.

Qualifications and Experience

• Bachelor’s degree, associate degree, diploma, or certificate in Quality or Validation fields. Relevant experience may substitute formal education criteria.
• At least 2 years of experience in manufacturing or quality environments.
• Demonstrated enthusiasm and interest in validation processes.
• Strong communication skills with ability to meet clear goals and drive progress efficiently.
• Capability to multitask and prioritize effectively.
• Robust problem-solving and troubleshooting abilities with proactive and dynamic approach.
• Self-driven and results-oriented mindset.
• Flexibility to work various shifts as business demands.
• Collaborative and adaptable team player.
• Proficiency in Microsoft Office suite, including Excel, PowerPoint, and Word.
• Experience working within GMP or regulated environments.

Preferred Additional Experience

• Familiarity with Lean Manufacturing principles and tools aimed at continuous improvement.

Equal Opportunity Statement

PCI Pharma Services proudly practices Equal Employment Opportunity and Affirmative Action. We do not discriminate based on any protected status including but not limited to race, color, religion, age, gender identity, disability, veteran status, or any other legally protected categories. We are devoted to fostering a diverse, inclusive workplace where everyone can thrive and feel a sense of belonging.