Actalent
Overview
Quality Validation Engineer role at Actalent. We are seeking a skilled and detail-oriented engineer to assist with equipment validations in pharmaceutical manufacturing. The successful candidate will ensure compliance with industry regulations by executing and overseeing equipment qualification processes, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), Cleaning Commissions, and Cleaning Validations. Additionally, this individual will be responsible for onboarding new equipment into the quality system. The role focuses on creating, reviewing, and executing validation documents and protocols to ensure our manufacturing processes and facilities meet the highest quality standards. Job Details Job Title: Quality Validation Engineer Job Type & Location: Contract to Hire — Mount Prospect, Illinois (onsite) Pay Range: $50.00 - $60.00/hr Work Environment: The candidate will work at the Mount Prospect site, which is the headquarters. The site operates under FDA and GMP guidelines and is undergoing expansion to support growth plans in the generic drug market. The role will begin in the staging room, move to the manufacturing floor, and eventually include a desk in the quality group. The manufacturing runs nine lines, all during the first shift from 8 am to 5 pm. The quality team consists of 6-8 members. Application Deadline: This position is anticipated to close on Sep 13, 2025. About Actalent: Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. The company is an equal opportunity employer. Reasonable accommodation requests may be sent to actalentaccommodation@actalentservices.com. Seniority level: Mid-Senior level Employment type: Contract Responsibilities
Develop and design detailed validation documents, including User Requirements Specifications (URS), IQ, OQ, PQ, and process validation protocols. Conduct comprehensive process validations and facility qualifications to ensure manufacturing processes adhere to company and regulatory standards. Lead cleaning validation efforts to ensure equipment cleaning processes meet regulatory and company standards for preventing cross-contamination and maintaining product integrity. Oversee facility qualification activities, ensuring all equipment and infrastructure meet necessary requirements and comply with validation standards. Draft and finalize validation reports, summarizing the results of tests, inspections, and data analyses to support quality and compliance efforts. Work closely with production, quality control, and regulatory teams to ensure all validation efforts align with regulatory standards and company policies. Essential Skills
Bachelor’s degree in Engineering, Quality, or a related field within chemistry, biology, physics, etc. 5 years of experience in validation within a pharmaceutical manufacturing environment. Strong understanding of validation protocols and documentation, including URS, IQ, OQ, PQ. Excellent written and verbal communication skills, with experience writing clear, concise reports. Familiarity with pharmaceutical regulatory requirements and standards (e.g., FDA, ISO). Additional Skills & Qualifications
Experience with compounding and packaging of liquid drug products (highly preferred). Experience with validation of computer systems (preferred). Experience with serialization (preferred). Benefits
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) Workplace & EEO
Work Environment: Fully onsite in Mount Prospect, IL. FDA and GMP guidelines apply. The role will involve steps from staging to manufacturing floor and quality group desk. Employer claims of equal opportunity and accommodations are included; for accommodations, email actalentaccommodation@actalentservices.com.
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Quality Validation Engineer role at Actalent. We are seeking a skilled and detail-oriented engineer to assist with equipment validations in pharmaceutical manufacturing. The successful candidate will ensure compliance with industry regulations by executing and overseeing equipment qualification processes, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), Cleaning Commissions, and Cleaning Validations. Additionally, this individual will be responsible for onboarding new equipment into the quality system. The role focuses on creating, reviewing, and executing validation documents and protocols to ensure our manufacturing processes and facilities meet the highest quality standards. Job Details Job Title: Quality Validation Engineer Job Type & Location: Contract to Hire — Mount Prospect, Illinois (onsite) Pay Range: $50.00 - $60.00/hr Work Environment: The candidate will work at the Mount Prospect site, which is the headquarters. The site operates under FDA and GMP guidelines and is undergoing expansion to support growth plans in the generic drug market. The role will begin in the staging room, move to the manufacturing floor, and eventually include a desk in the quality group. The manufacturing runs nine lines, all during the first shift from 8 am to 5 pm. The quality team consists of 6-8 members. Application Deadline: This position is anticipated to close on Sep 13, 2025. About Actalent: Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. The company is an equal opportunity employer. Reasonable accommodation requests may be sent to actalentaccommodation@actalentservices.com. Seniority level: Mid-Senior level Employment type: Contract Responsibilities
Develop and design detailed validation documents, including User Requirements Specifications (URS), IQ, OQ, PQ, and process validation protocols. Conduct comprehensive process validations and facility qualifications to ensure manufacturing processes adhere to company and regulatory standards. Lead cleaning validation efforts to ensure equipment cleaning processes meet regulatory and company standards for preventing cross-contamination and maintaining product integrity. Oversee facility qualification activities, ensuring all equipment and infrastructure meet necessary requirements and comply with validation standards. Draft and finalize validation reports, summarizing the results of tests, inspections, and data analyses to support quality and compliance efforts. Work closely with production, quality control, and regulatory teams to ensure all validation efforts align with regulatory standards and company policies. Essential Skills
Bachelor’s degree in Engineering, Quality, or a related field within chemistry, biology, physics, etc. 5 years of experience in validation within a pharmaceutical manufacturing environment. Strong understanding of validation protocols and documentation, including URS, IQ, OQ, PQ. Excellent written and verbal communication skills, with experience writing clear, concise reports. Familiarity with pharmaceutical regulatory requirements and standards (e.g., FDA, ISO). Additional Skills & Qualifications
Experience with compounding and packaging of liquid drug products (highly preferred). Experience with validation of computer systems (preferred). Experience with serialization (preferred). Benefits
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) Workplace & EEO
Work Environment: Fully onsite in Mount Prospect, IL. FDA and GMP guidelines apply. The role will involve steps from staging to manufacturing floor and quality group desk. Employer claims of equal opportunity and accommodations are included; for accommodations, email actalentaccommodation@actalentservices.com.
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