A validation and quality assurance provider are looking to hire a Validation Engineer-Aseptic Processing on a temporary assignment located in Petersburg, VA.Hourly rate $60.00 to $65.00 Job Summary:
We are seeking a skilled Validation Engineer with expertise in aseptic processing and equipment/system qualification (IQ/OQ/PQ) to support our pharmaceutical or biotech manufacturing operations. The ideal candidate will ensure compliance with regulatory standards (FDA, EU GMP, etc.), and lead validation activities for cleanrooms, equipment, utilities, and processes. Key Responsibilities:
Develop and execute validation protocols (IQ/OQ/PQ) for equipment, cleanrooms, HVAC systems, autoclaves, lyophilizers, filling lines, and other critical aseptic systems.
Lead validation efforts for new and existing aseptic manufacturing processes.
Draft and review validation documentation, including risk assessments, protocols, reports, SOPs, and change controls.
Coordinate validation activities with cross-functional teams (engineering, QA, manufacturing, and regulatory).
Ensure compliance with cGMP, FDA, EMA, and other regulatory guidelines during validation activities.
Support inspection readiness and participate in regulatory audits.
Conduct gap assessments and revalidation as needed.
Provide training and guidance on validation procedures and aseptic techniques.
Qualifications:
Bachelor’s degree in Engineering, Life Sciences, or related field.
3–7+ years of validation experience in a regulated pharmaceutical/biotech environment.
Hands-on experience with aseptic processing, cleanroom qualification, and environmental monitoring systems.
Proven expertise in preparing and executing IQ/OQ/PQ protocols.
Strong understanding of cGMPs, FDA guidelines (21 CFR Part 11, 210/211), and ICH Q7/Q9/Q10.
Excellent documentation, communication, and organizational skills.
Preferred Qualifications:
Experience with automated fill/finish equipment.
Knowledge of Annex 1 and current aseptic manufacturing best practices.
Familiarity with validation of computerized systems (CSV).
Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
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