Quality Validation Engineer

Job description

Job Description Job Description Job Title: Quality Validation EngineerJob Description We are seeking a skilled and detail-oriented Quality Validation Engineer to assist with equipment validations for pharmaceutical manufacturing.

The successful candidate will play a key role in ensuring 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.

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

Collaborate 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 such as chemistry, biology, or physics.

At least 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).

Work Environment The position is based at the Mount Prospect site, which serves as the headquarters.

The candidate will initially work in the staging room and then transition to the manufacturing floor and quality group, where they will have a desk.

The manufacturing facility operates 9 lines, all on the first shift, from 8 am to 5 pm.

The quality team consists of 6-8 members.

The company follows FDA and GMP guidelines, and the facility is focused on expanding its presence in the generic drug market and European market.

The company has a strong growth plan, including changes in the quality team to ensure FDA compliance.

Job Type & Location This is a Contract to Hire position based out of Mount Prospect, Illinois.

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 Nov 1, 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.

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 actalentaccommodation@actalentservices.com for other accommodation options.

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