Validation Specialist

About PCI Pharma Services

At PCI Pharma Services, we are dedicated to delivering life-changing therapies and making a global impact. We partner with thousands of biopharma companies and their patients, investing in people who drive innovation and progress. Our strategy involves building strong teams within our global network to pioneer the future of pharmaceutical services.

Role Overview

We are seeking a Validation Specialist to join our team full-time in Stamullen, County Meath, Ireland. This permanent position requires working on-site Monday to Friday. The core responsibility of this role is to implement and execute validation activities related to processes, facilities, and equipment at PCI Pharma Services sites, ensuring compliance with regulatory requirements and client expectations.

Key Areas of Validation

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

Primary Responsibilities

• Maintain safe work practices consistently and report any safety incidents promptly to the Environmental Health and Safety (EHS) Department.
• Ensure all validation tasks pertaining to facilities, equipment, and processes comply with client specifications and regulatory standards such as HPRA and FDA guidelines.
• Adhere to the Site Validation Master Plan in all validation activities.
• Develop validation protocols for new and existing computer systems, equipment, facilities, and processes; review and approve validation reports; and maintain cleaning validation documentation for Irish sites.
• Carry out validation executions with minimal supervision while collaborating closely with Technical, Production, and Engineering departments.
• Conduct sampling activities supporting validation studies including Acceptable Quality Level (AQL) and cleaning validation testing.
• Manage tooling validations alongside associated documentation thoroughly.
• Strictly follow validation procedures and ensure timely, accurate preparation of all validation records.
• Assist with investigations related to complaints, deviations, and change control processes as necessary.
• Take on additional tasks and manage specific or ad hoc projects aligned with operational needs and competency scope.
• Identify and support initiatives for process and procedure improvements.
• Perform periodic reviews and conduct revalidations based on schedule requirements.
• Collaborate with the Validation team to maintain a robust, compliant validation system consistent with industry standards and current regulatory directives.
• Fulfill other related duties as required to support organizational goals.

Required Qualifications and Experience

• Bachelor’s degree, associate degree, diploma, or certificate in Quality, Validation, or related fields; relevant experience may substitute formal education requirements.
• At least 2 years of professional experience in Manufacturing or Quality environments.
• Strong enthusiasm and genuine interest in Validation processes.
• Ability to follow clear objectives, communicate effectively, and ensure project completion within target timelines.
• Capability to prioritize and handle multiple tasks efficiently.
• Proficient problem-solving and troubleshooting skills with a proactive and dynamic approach to challenges.
• Self-driven with a results-oriented mindset.
• Flexibility to work various shifts based on business demands.
• Adaptability and aptitude for collaboration across teams.
• Proficiency in Microsoft Office applications such as Excel, PowerPoint, and Word.
• Experience working in Good Manufacturing Practice (GMP) or similarly regulated environments.

Preferred Skills

• Knowledge and experience with Lean Manufacturing principles and continuous improvement methodologies using Lean tools.

Equal Opportunity and Inclusion

PCI Pharma Services is committed to equal opportunity employment. We do not discriminate on any protected status including but not limited to race, religion, gender identity, age, disability, or veteran status. Our company culture prioritizes equity and inclusivity by maintaining high standards of respect, fairness, and equal opportunity in every aspect of our workplace. We continuously assess and improve our policies and practices to foster a community where everyone can belong and develop.