Quality Validation Engineer

Job Title: Quality Validation EngineerJob Description

We are seeking a skilled and detail-oriented Quality Validation Engineer to play a crucial role in equipment validations for pharmaceutical manufacturing and laboratory settings. 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. This role involves creating, reviewing, and executing validation documents and protocols to maintain the highest quality standards in our manufacturing processes and facilities.

Responsibilities

• Develop and design detailed validation documents, including User Requirements Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and process validation protocols.

• Conduct comprehensive process validations and facility qualifications to ensure adherence to company and regulatory standards.

• Lead cleaning validation efforts to ensure equipment cleaning processes meet standards for preventing cross-contamination and maintaining product integrity.

• Oversee facility qualification activities, ensuring all equipment and infrastructure comply with validation standards.

• Draft and finalize validation reports, summarizing the results of tests, inspections, and data analyses.

• Collaborate closely with production, quality control, and regulatory teams to ensure alignment with regulatory standards and company policies.

Essential Skills

• 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

• Bachelor's degree in Engineering, Chemistry, Biology, Physics, or a related field.

• Experience with compounding and packaging of liquid drug products (highly preferred).

• Experience with validation of computer systems (preferred).

• Experience with serialization (preferred).

Work Environment

The candidate will work at the Mount Prospect site, starting in the staging room before moving to the manufacturing floor and quality group. The manufacturing operates 9 lines, all on the first shift from 8 am to 5 pm. The Quality team consists of 6-8 members, and the company follows FDA and GMP guidelines. The company has a strong growth plan for its future in the generic drug and European markets, with ongoing expansion to ensure FDA compliance.

Job Type & Location

This is a Contract to Hire position based out of Mount Prospect, IL.

Pay and Benefits

The pay range for this position is $50.00 - $60.00/hr.

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)

Workplace Type

This is a fully onsite position in Mount Prospect,IL.

Application Deadline

This position is anticipated to close on Feb 28, 2026.

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. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.