Hiring: Specialist, QA Validation & Engineering Company: Catalent Location: Harmans, MD Job Posted Time: 2026-09-10 11:32:21 Employment Type: On-site Target Skills & Keywords : Quality Assurance About the job Experience: •1-3 years of experience in a GMP-regulated pharmaceutical, biotechnology, or biologics manufacturing environment. •3 years of experience in a GMP-regulated pharmaceutical, biotechnology, or biologics manufacturing environment. Required Skills: •Act as Quality Assurance representative for review and approval of process validation lifecycle documents, including Validation Master Plans, Process Performance Qualification protocols and reports, engineering and characterization studies, and Continued Process Verification documentation. •Provide QA oversight throughout the process validation lifecycle to ensure compliance with regulatory requirements, industry standards, and internal procedures. •Support cleaning validation programs through protocol and report review and approval. •Partner cross-functionally with Manufacturing, Process Development, Validation, Engineering, and Technical Services teams to support process validation programs and continuous improvement initiatives. •Review and approve deviations, investigations, corrective and preventive actions, and risk assessments related to process validation activities. •Review and approve change controls impacting validated manufacturing processes, ensuring proper assessments, implementation plans, and supporting validation documentation. •Support client, regulatory, and internal audits by providing subject matter expertise on process validation programs and quality systems. •Support QA review of qualification activities for manufacturing equipment, process equipment, cleanrooms, facilities, and GMP utilities. Qualifications: •Bachelor's degree in Engineering, Life Sciences, Pharmacy, Biotechnology, Chemistry, Microbiology, or a related scientific discipline. •Minimum 1-3 years of experience in a GMP-regulated pharmaceutical, biotechnology, or biologics manufacturing environment. •Strong knowledge of FDA, EMA, ICH, and current Good Manufacturing Practice requirements applicable to process validation. •Operational familiarity with biologics, cell therapy, gene therapy, plasmid manufacturing, or sterile manufacturing processes. Compensation: •$70,000 - $90,000 / year •The anticipated salary range for this position in MD is $70,000 – $90,000 Plus Bonus Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!