Validation Engineer
Contract: 6+ month duration with potential for extensions
Location: Woodstock, IL - ONSITE
Shift: First-shift hours; flexibility to support project timelines required
Industry: Sterile Liquids Manufacturing
Automated Systems, Inc. is seeking a highly capable Validation Engineer to support validation activities for Blow-Fill-Seal (BFS) equipment, with additional scope across compounding and packaging systems.
You will be working within a dynamic CDMO environment specializing in ophthalmic, inhalation, and irrigation products, helping to ensure all systems meet current Good Manufacturing Practices (cGMP), FDA, and client quality expectations.
Key Responsibilities:
- Lead and execute validation lifecycle documentation (URS, IQ, OQ, PQ) for Blow-Fill-Seal equipment used in sterile liquid product manufacturing.
- Support validation of compounding systems, including mixers, tanks, and associated CIP/SIP systems.
- Perform packaging line validation for sterile fill finish operations.
- Collaborate with cross-functional teams (QA, Engineering, Operations) to execute validation deliverables according to project timelines.
- Write and manage change controls, deviations, and CAPAs related to validation activities.
- Ensure all validation work aligns with internal SOPs, regulatory expectations, and customer-specific requirements.
- Assist in audit readiness activities and represent the validation function during inspections or client visits.
- Contribute to continuous improvement initiatives by identifying gaps and optimizing validation practices.
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, Pharmacy, or related technical field.
- Minimum 4 years of experience in pharmaceutical or medical device manufacturing.
- 4+ years of direct validation experience, including hands-on protocol generation and execution.
Preferred Qualifications:
- Strong understanding of BFS technology, sterile processes, and related regulatory standards (21 CFR Part 11, EU Annex 1, etc.).
- Experience in CDMO environments and third-party client interactions is preferred.
- Familiarity with ASTM E2500, GAMP 5, and risk-based validation approaches.
