Validation Engineer

The Validation Engineer will lead and execute equipment qualification, process validation, cleaning validation, and OCMC procedure development to support a CGMP validation program. This role requires end-to-end ownership of validation deliverables across a range of pharmaceutical manufacturing systems, ensuring full lifecycle traceability and alignment with regulatory expectations.

Responsibilities

• Execute installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for pharmaceutical manufacturing equipment, including tablet machines, ampule fillers, tube fill and sealers, herb dryers, and incubators.
• Author clear, comprehensive validation protocols and reports that meet CGMP and regulatory requirements.
• Ensure full lifecycle traceability from user requirements specifications (URS) through IQ/OQ/PQ execution to final validation reporting.
• Contribute to the development and execution of the Validation Master Plan for manufacturing systems.
• Develop robust cleaning validation strategies and protocols for product-contacting equipment, including acceptance criteria and sampling plans.
• Coordinate cleaning validation samples with contract testing laboratories and ensure timely, accurate testing and documentation.
• Design and implement OCMC (Operation, Cleaning, Maintenance, and Calibration) procedures that support and maintain the validated state of equipment.
• Establish acceptance limits and design swab sampling, rinse sampling, and residue recovery studies to verify cleaning effectiveness.
• Collaborate closely with Operations, Quality, and Leadership teams to align validation activities with business and production needs.
• Explain regulatory and validation requirements in practical, business-focused terms to non-quality personnel and support their understanding of compliance obligations.
• Influence stakeholders without direct authority to build consensus on validation strategies, procedures, and documentation requirements.
• Support change implementation in environments with developing quality systems, maintaining patience and adaptability while driving compliance.

• 4–8 years of experience in pharmaceutical equipment validation.
• Demonstrated experience developing and executing IQ, OQ, and PQ protocols for pharmaceutical manufacturing equipment.
• Strong expertise in equipment qualification, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Proven experience leading cleaning validation projects from protocol development through report approval.
• Experience establishing acceptance limits, swab sampling, rinse sampling, and residue recovery studies for cleaning validation.
• Hands-on experience with process validation in a CGMP environment.
• Experience qualifying filling, packaging, processing, or production equipment, including liquid, ampule, and tube filling systems.
• Experience developing Operation, Cleaning, Maintenance, and Calibration (OCMC) procedures to maintain the validated state of equipment.
• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• Strong understanding of CGMP principles and validation testing methodologies.
• Ability to explain regulatory and validation requirements in practical, business-oriented language to non-quality stakeholders.
• Ability to balance compliance objectives with operational realities while maintaining regulatory expectations.

• Experience working in organizations with low process maturity or developing quality systems, with the ability to help shape and strengthen validation practices.
• Comfort influencing stakeholders without direct authority and building consensus across Operations, Quality, and Leadership teams.
• Patient, adaptable approach to implementing new procedures and documentation requirements in environments that may be resistant to change.
• Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
• Ability to prioritize and manage multiple validation activities while maintaining accuracy and compliance.
• Demonstrated capability to contribute to and execute a Validation Master Plan.
• Attention to detail in authoring validation protocols, reports, and OCMC procedures.

The role operates within a CGMP pharmaceutical manufacturing environment that includes equipment such as tablet machines, ampule fillers, tube fill and sealers, herb dryers, and incubators. The Validation Engineer works closely with Operations, Quality, and Leadership teams and collaborates with external contract testing laboratories for sample analysis. The position involves both documentation-focused work and hands-on activities on the production floor, following appropriate safety and compliance procedures. The environment emphasizes regulatory compliance, continuous improvement of validation and quality systems, and practical alignment of validation activities with manufacturing operations.

Job Type & Location

This is a Contract position based out of East Troy, WI.

The pay range for this position is $60.00 - $65.00/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)

This is a fully onsite position in East Troy,WI.

This position is anticipated to close on Jul 11, 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 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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall 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 applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $60 - $65