Validation Engineer
Listed on 2026-10-05
-
Quality Assurance - QA/QC
Quality Engineering -
Engineering
Quality Engineering
Validation Engineer
Job Description
We are seeking a Validation Engineer to author, execute, and maintain validation protocols, reports, and supporting documentation. You will support equipment qualification and process validation activities, including IQ/OQ/PQ, and lead validation efforts for manufacturing equipment, systems, and production processes. Additionally, you will support change control, deviation investigations, root cause analysis, and CAPA activities, analyze validation data, and prepare detailed technical reports.
Responsibilities- Author, execute, and maintain validation protocols, reports, and supporting documentation.
- Support equipment qualification and process validation activities including IQ/OQ/PQ.
- Lead validation efforts for manufacturing equipment, systems, and production processes.
- Support change control, deviation investigations, root cause analysis, and CAPA activities.
- Analyze validation data and prepare detailed technical reports.
- Partner with Quality, Manufacturing, Engineering, and Laboratory teams to support validation projects.
- Develop and maintain SOPs, validation master plans, process flow diagrams, and related documentation.
- Ensure compliance with FDA, cGMP, and internal quality requirements.
- Participate in validation activities associated with new equipment, process improvements, and product changes.
- Support audit readiness and continuous improvement initiatives.
- Prioritize multiple projects and manage competing deadlines in a fast-paced manufacturing environment.
- Bachelor's degree in Engineering, Biology, Microbiology, Chemistry, Quality, or a related scientific discipline.
- Minimum of 2 years of validation experience in a regulated manufacturing environment.
- Experience writing and executing validation protocols and reports.
- Experience supporting equipment qualification and process validation activities.
- Knowledge of FDA regulations and cGMP.
- Strong technical writing and documentation skills.
- Ability to manage multiple priorities and adapt to changing business needs.
Skills & Qualifications
- Pharmaceutical manufacturing experience.
- Experience validating mixing processes and manufacturing equipment.
- Experience with stainless steel mixing tanks.
- Process validation and equipment qualification experience.
- Microbiology experience.
- Experience in medical device, nutraceutical, cosmetic, food, or chemical manufacturing industries.
- Experience supporting CAPA, deviation investigations, and change control processes.
This position is within a manufacturing company and operates on a Monday to Friday schedule from 8 AM to 5 PM. The environment is fast-paced, requiring adaptability and strong organizational skills. The role is a contract-to-hire opportunity, open to candidates with a minimum of 2 years of experience. The company values candidates with experience in highly regulated manufacturing environments, particularly those with pharmaceutical or related industry backgrounds.
Job Type & LocationThis is a Contract to Hire position based out of Elgin, IL.
Pay and BenefitsThe pay range for this position is $50.00 - $53.00/hr.
Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)
This is a fully onsite position in Elgin,IL.
Final date to receive applicationsThis position is anticipated to close on Oct 10, 2026.
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