Validation Engineer

Job Title: Validation Engineer 

Contract: 6-month duration 

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. This is a 6-month contract opportunity, ideal for engineers with a strong foundation in sterile manufacturing and hands-on validation execution.

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 2 years of experience in pharmaceutical or medical device manufacturing.
• 1+ 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.