Validation Specialist

About the Role

Join a leading pharmaceutical contract manufacturing company based in Stamullen, County Meath, as a Validation Specialist. This is a permanent full-time position, working onsite Monday to Friday. This role focuses on implementing and executing validation activities related to processes, equipment, and facilities within PCI Pharma Services sites, ensuring compliance with regulatory standards and client expectations.

Responsibilities

• Adhere strictly to safety protocols and report any near misses immediately to the Environmental Health and Safety Department.
• Conduct validation tasks concerning facilities, equipment, and processes, ensuring alignment with HPRA and FDA regulatory requirements.
• Follow the Site Validation Master Plan thoroughly.
• Develop, review, and approve validation protocols and reports for new and current computer systems, facilities, equipment, and cleaning processes.
• Carry out validation activities with minimal supervision, collaborating closely with technical, production, and engineering teams.
• Collect and analyze samples to support validation studies such as AQL and cleaning validation.
• Oversee tooling validations and maintain related documentation accurately.
• Ensure timely and precise completion of all validation documentation, maintaining strict adherence to validation procedures.
• Support investigations related to complaints, deviations, and change controls as needed.
• Manage ad hoc projects and tasks aimed at meeting business objectives within the scope of the role.
• Identify opportunities to improve processes and procedures continuously.
• Perform scheduled periodic reviews and revalidations to maintain validation integrity.
• Collaborate with the validation team to uphold a robust and compliant validation system aligned with industry standards and current regulatory guidelines.
• Undertake additional tasks aligned with company objectives as required.

Essential Qualifications and Experience

• Bachelor’s degree, associate degree, diploma, or certificate in Quality or Validation-related fields; equivalent experience may be considered in place of formal education.
• At least two years of experience in manufacturing or quality environments.
• A demonstrated interest and competence in validation processes.
• Strong ability to follow objectives, communicate effectively, and ensure successful completion of tasks on time.
• Capability to manage multiple priorities and adapt to changing workloads.
• Proficient problem-solving and troubleshooting skills with a proactive and dynamic approach.
• Self-driven and results-oriented mindset.
• Willingness and flexibility to work different shifts as business needs dictate.
• Ability to work well with others in a collaborative environment.
• Proficiency with Microsoft Office suite, including Excel, PowerPoint, and Word.
• Experience working in GMP-regulated or comparable regulated environments.

Desirable Attributes

• Familiarity with Lean Manufacturing principles and tools to promote continuous improvement initiatives.

Equal Employment Opportunity

The employer is committed to providing equal employment opportunities without discrimination based on race, color, religion, age, gender, national origin, disability, veteran status, or any other protected characteristic. The company fosters an inclusive workplace culture encouraging respect, fairness, and equal opportunity for all employees.