Role: Process Engineering & Validation Expert
City: US-St. Louis - MO
Type: 100% Onsite
Description:
Validation activities include qualification and re-qualification of facilities, equipment, computer systems, utilities, equipment and cleanroom qualifications.
• Provide support to site facilities, utilities, and equipment qualifications.
• Prepare validation and commissioning protocols and protocols final reports.
• Execute approved protocols, i.e., autoclaves, temperature chambers, vacuum ovens etc.
• Prepare and execute revalidation protocols and protocol final reports with validated equipment.
Minimum Qualifications
• Bachelor’s degree in an Engineering or Life Sciences discipline and/or 4-5 years equivalent practical experience
• Competent in regulations including ISPE, PDA, USP, ICH and US 21CFR Parts 11, 210 and 211.
Preferred Qualifications:
• Experience in technical writing preparing protocols and protocols final reports.
• Mechanical aptitude required. Possess critical thinking skills to troubleshoot and commission equipment/processes.
• Proficient in Microsoft Office Applications.
• Excellent communication skills, both oral and written. Ability to work as part of a team.
• Must be able to read, understand and follow cGMPs, SOPs, Specs, and all guidelines as they relate to the process.
• Time management skills and the ability to manage oneself. Projects must be completed in a timely manner and per the testing timelines.
• Superior attention to detail.
• Experience in interaction with regulatory bodies.
• Knowledge of API products and CMO is desirable but not essential.
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