Quality Validation Engineer

Job Description

Job Description

Job Title: Quality Validation Engineer Job Description

This Quality Validation Engineer role focuses on equipment and process validation for pharmaceutical manufacturing and laboratory-related systems. You will create, review, and execute validation documents and protocols to ensure that manufacturing processes, facilities, and equipment meet stringent regulatory and quality standards. The position plays a critical role in maintaining compliance by overseeing equipment qualification activities, onboarding new equipment into the quality system, and supporting cross-functional teams in a highly regulated pharmaceutical environment.

Responsibilities

• Develop, design, and maintain detailed validation documentation, including User Requirements Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and process validation protocols.
• Execute and oversee equipment qualification processes such as IQ, OQ, PQ, Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), Cleaning Commissions, and Cleaning Validations for pharmaceutical manufacturing and related equipment.
• Conduct comprehensive process validations and facility qualifications to ensure manufacturing processes and infrastructure adhere to internal quality standards and applicable regulatory requirements.
• Lead cleaning validation activities to confirm that equipment cleaning procedures prevent cross-contamination and maintain product integrity in accordance with regulatory and company standards.
• Oversee facility and equipment qualification activities, ensuring that all systems, utilities, and production equipment meet defined requirements and comply with validation and quality system standards.
• Draft, review, and finalize validation reports, clearly summarizing test results, inspections, and data analysis to support quality assurance and regulatory compliance.
• Perform batch record review and related documentation checks to ensure accuracy, completeness, and compliance with Good Manufacturing Practices (GMP).
• Support equipment validation and quality systems activities related to liquid drug products, including compounding and packaging processes.
• Collaborate closely with production, quality control, quality assurance, and regulatory teams to align validation activities with company policies, FDA guidelines, GMP requirements, and industry standards.
• Participate in serialization-related validation efforts and ensure that serialization processes and systems meet applicable regulatory and customer requirements.
• Contribute to continuous improvement of validation procedures, documentation practices, and quality systems as the site expands and introduces new products.
• Assist with onboarding new equipment into the quality system, including documentation, qualification, and integration into existing processes.
• Produce clear, concise, and well-structured validation documentation and reports that can be easily understood and audited.
• Support adherence to FDA, ISO, and GMP guidelines in all validation and quality assurance activities.

Essential Skills

• Approximately 5 years of experience in validation within a pharmaceutical manufacturing environment.
• Strong understanding of validation protocols and documentation, including URS, IQ, OQ, and PQ.
• Hands-on experience with equipment validation and process validation in a GMP-regulated pharmaceutical setting.
• Proficiency in developing, executing, and managing validation documents and protocols for manufacturing processes, facilities, and equipment.
• Experience with cleaning validation and cleaning commissions to prevent cross-contamination and ensure product integrity.
• Ability to conduct and document Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) for new and existing equipment.
• Solid background in quality control and quality assurance, including batch record review and validation reports.
• Strong documentation skills, with the ability to write clear, concise, and accurate validation reports and quality-related documentation.
• Familiarity with pharmaceutical regulatory requirements and standards such as FDA and ISO, and with GMP guidelines.
• Knowledge of quality systems and their application in pharmaceutical manufacturing environments.
• Excellent written and verbal communication skills for effective collaboration with cross-functional teams.
• Ability to work with liquid drug products, including an understanding of compounding and packaging processes.
• Attention to detail and strong analytical skills for interpreting test data and inspection results.
• Capability to manage multiple validation activities in a dynamic, growth-oriented manufacturing environment.

Additional Skills & Qualifications

• Bachelors degree in Engineering, Quality, Chemistry, Biology, Physics, Material Science, Chemical Engineering, or a closely related scientific or technical field.
• Experience with compounding and packaging of liquid drug products is highly preferred.
• Experience with validation of computer systems is preferred.
• Experience with serialization processes and related validation activities is preferred.
• background in sciences such as biology and chemistry, or in engineering disciplines, is beneficial.
• Knowledge of documentation best practices within quality systems, including report writing and record management.
• Understanding of pharmaceutical manufacturing operations, including multiple production lines and staging areas.
• Ability to thrive in a quality-focused environment undergoing growth and change to support expanded product portfolios and markets.
• Comfort working both in manufacturing areas and in an office-based quality group setting.

Work Environment

This role is based at a pharmaceutical manufacturing site that serves as the headquarters and primary production location for liquid drug products, including CHG solutions and prescription oral rinses. The company has a strong growth plan in the generic drug and European markets and is expanding the site as it acquires new products and enhances its quality team to ensure ongoing FDA compliance while scaling revenue. Manufacturing operations run nine production lines on first shift, and this position follows a standard first shift schedule of approximately 8:00 a.m. to 5:00 p.m. The Quality Validation Engineer will not work directly in the laboratory but will begin in the staging room, spend time on the manufacturing floor, and also work within the quality group with an assigned desk. The quality team consists of several professionals, providing a collaborative environment with opportunities to grow within quality assurance and validation. The facility operates under FDA and GMP guidelines, and you will work with established quality systems, validation protocols, and regulated manufacturing processes in a structured, compliance-driven setting at the Mount Prospect site.

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.

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)

Workplace Type

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

Application Deadline

This position is anticipated to close on Oct 10, 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on us.fitly.work for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.