The Validation Engineer is responsible for executing, maintaining, and continuously improving site validation activities to ensure that equipment, utilities, facilities, processes, and systems remain in a qualified and validated state and comply with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements. This role supports the implementation of the Validation Master Plan (VMP) and the execution of qualification, process validation, cleaning validation, and continued process verification (CPV) activities throughout the product lifecycle. The Validation Engineer collaborates closely with Manufacturing, Engineering, Quality Assurance, Quality Control, and Regulatory Affairs to ensure robust validation practices, data integrity, product quality, patient safety, and ongoing inspection readiness.
Key Responsibilities:- Execute validation and qualification activities for pharmaceutical manufacturing processes, equipment, utilities, facilities, cleaning procedures, and computerized systems in accordance with approved procedures and regulatory requirements.
- Support the implementation and maintenance of the site Validation Master Plan (VMP), ensuring validation activities are performed in accordance with established timelines, site priorities, and applicable cGMP requirements.
- Develop, execute, and maintain validation lifecycle documentation, including validation protocols, qualification documents, test scripts, technical assessments, and final reports.
- Support process validation activities, including process performance qualification (PPQ), performance qualification (PQ), and continued process verification (CPV), to demonstrate and maintain process consistency and control.
- Collaborate with Engineering, Manufacturing, and Quality Assurance to assess new equipment, facilities, utilities, manufacturing processes, and system modifications requiring qualification or validation.
- Prepare, review, and execute validation protocols and reports, ensuring that acceptance criteria are met, deviations are appropriately documented, and results are scientifically justified and traceable.
- Participate in quality risk assessments, including Failure Mode and Effects Analysis (FMEA), to identify potential risks and establish appropriate qualification, validation, and control strategies.
- Ensure validation documentation is accurate, complete, compliant, and maintained in accordance with approved procedures, document control requirements, and data integrity principles.
- Support regulatory inspections, internal audits, and customer audits by providing validation documentation, technical information, and evidence of compliance with applicable regulatory requirements.
- Support the execution and monitoring of the Continuous Process Verification (CPV) program by reviewing process data, identifying trends, evaluating process performance, and escalating potential issues that may affect the validated state.
- Investigate validation-related deviations, discrepancies, and unexpected results; support root cause analysis and implement corrective and preventive actions (CAPAs) as required.
- Participate in change control assessments to evaluate the impact of changes to equipment, utilities, facilities, processes, procedures, and computerized systems on the qualified or validated state.
- Identify opportunities to improve validation processes, documentation practices, and execution efficiency while maintaining compliance with FDA, EMA, ICH Q8–Q10, EU GMP Annex 15, and applicable company procedures.
- Provide technical support and validation expertise to cross-functional teams during equipment commissioning, qualification, process implementation, troubleshooting, and facility or manufacturing changes.
- Maintain current knowledge of applicable regulatory guidance, industry standards, and validation best practices to support a compliant and effective pharmaceutical quality system.
- Qualifications / Experience
- Bachelor’s degree in Engineering, Life Sciences, Pharmacy, or related discipline
- Minimum 3 years, 5 years preferred of experience in pharmaceutical or biotechnology validation
- Strong knowledge of FDA cGMPs, ICH Q8–Q10, EU Annex 15, and validation best practices
- Experience with sterile injectable manufacturing, aseptic processes, utilities, and equipment qualification
- Experience with commissioning, qualification, and validation in a startup (greenfield) or expansion environment preferred
- Hands on experience with data logger and steam sterilization qualifications
- Skills / Competencies
- Strong technical writing and documentation review skills
- Ability to manage multiple projects and prioritize in a fast-paced environment
- Expertise in sterile systems, process validation, cleaning validation, and computer system validation
- Excellent cross-functional communication, influencing, and collaboration skills
- Strong analytical, risk-based decision-making, and problem-solving skills
- Commitment to data integrity, patient safety, and product quality
