Quality Assurance Engineer - Validation

Quality Engineer – Pharmaceutical Manufacturing Seeking a Quality Engineer to lead quality assurance activities across the pharmaceutical product lifecycle, from development through validation and commercial production. This role involves applying cGMP principles, managing validation protocols (IQ / OQ / PQ), analyzing process data, and supporting cross-functional teams to ensure compliance, efficiency, and product quality. Ideal candidates will have experience in pharmaceutical manufacturing, strong statistical and project management skills, and a solid understanding of regulatory requirements.

Essential Duties and Responsibilities Develop, implement, and maintain the company's pharmaceutical quality assurance strategy across all stages of product development and manufacturing, in alignment with cGMP and ICH Q8 / Q9 / Q10 guidelines. Lead the planning and execution of quality assurance deliverables and product testing activities, ensuring compliance with regulatory requirements and internal standards for new drug product launches. Perform statistical analysis of process and product performance data to assess capability and ensure conformance to internal and regulatory specifications. Author and review validation protocols and reports (IQ / OQ / PQ) in accordance with FDA, EMA, and other global regulatory expectations. Provide guidance to quality personnel on procedures for sampling, testing, and data documentation in compliance with Good Laboratory Practices (GLP). Collaborate cross-functionally with R&D, Regulatory Affairs, Manufacturing, and Supply Chain teams to support daily operations and continuous improvement initiatives. Support new product introductions by ensuring robust and compliant manufacturing processes that are efficient and cost-effective. Manage multiple projects and timelines across various pharmaceutical programs and clients.

Required Competencies, Skills, and Experience Experience in pharmaceutical manufacturing, including solid oral dosage, sterile injectables, or biologics preferred. Strong understanding of cGMP, FDA 21 CFR Part 210 / 211, EU GMP, and ICH guidelines. Proficient in process validation lifecycle (IQ / OQ / PQ), risk management (FMEA), and quality risk assessments. Familiarity with statistical tools and software (e.g., Minitab) for data analysis and process capability studies. Knowledge of Measurement System Analysis (MSA) and equipment qualification is desirable. Proficient in reading and interpreting technical specifications, batch records, and validation documentation. Strong project management and time management skills. Excellent written and verbal communication skills, including experience with regulatory audits and customer interactions. Commitment to quality, compliance, and continuous improvement.

Education and Job Experience Requirements Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related technical field (or equivalent experience). Minimum of 3-5 years of experience in a pharmaceutical quality engineering or validation role.

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