Validation Engineer

Job Description

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.Company Description

We are a dynamic, project oriented consulting company offering individuals a wide variety of technical challenges. We are currently experiencing rapid growth, and are in need of talented individuals. ASI offers top wages and excellent benefits. ASI is an equal opportunity employer.