Validation Engineer (Contractor)

Job Title: Validation Engineer (Contractor) Job Description This contract Validation Engineer role supports a large-scale biopharmaceutical manufacturing facility by leading equipment qualification and cleaning validation activities across both stainless steel and single-use operations. You will author, execute, and summarize validation protocols for GMP manufacturing equipment and cleaning processes, ensuring they meet regulatory expectations and internal quality standards. The position requires deep hands-on validation experience, strong technical writing skills, and the ability to collaborate effectively with cross-functional teams while independently managing timelines and deliverables. Responsibilities

- Author, review, and execute equipment qualification protocols (IQ, OQ, PQ) for a variety of manufacturing systems and equipment, including bioreactors, chromatography skids, TFF systems, and autoclaves.
- Develop, author, and execute cleaning validation and cleaning verification protocols, including detailed sampling plans, visual inspection criteria, and coordination of analytical testing such as TOC, conductivity, bioburden, and endotoxin.
- Evaluate validation test results against predefined acceptance criteria, identify and troubleshoot execution discrepancies, and document protocol exceptions in collaboration with cross-functional stakeholders.
- Perform hands-on validation activities for Clean-in-Place (CIP) and Steam-in-Place (SIP) systems, including residue limit assessments and recovery studies for commercial stainless steel and single-use manufacturing facilities.
- Document all validation activities thoroughly, maintain accurate records, and ensure traceability and data integrity in alignment with cGMP and internal quality requirements.
- Support continuous improvement of validation processes by identifying opportunities to streamline protocols, enhance testing strategies, and improve documentation practices.
- Ensure all qualification and validation deliverables comply with current industry standards, regulatory expectations, and internal quality standards related to cGMP and GMP.
- Collaborate closely with manufacturing, quality, and engineering teams to align validation activities with production schedules and project timelines.
- Independently manage validation timelines and workload to meet project milestones and operational needs.
- Contribute technical input and expertise during internal discussions, audits, and inspections related to equipment and cleaning validation.

Essential Skills

- 810 years of direct validation engineering experience within a cGMP biopharmaceutical or biotechnology manufacturing facility.
- Proven, hands-on experience authoring and executing equipment validation protocols (IQ, OQ, PQ) for bioreactors, chromatography skids, TFF systems, and autoclaves.
- Direct experience with cleaning validation, including CIP and SIP systems, residue limit determination, and recovery studies.
- Strong understanding of cGMP and GMP requirements in biopharma and biologics manufacturing environments.
- Demonstrated proficiency in protocol authoring and execution for both equipment qualification and cleaning validation activities.
- Experience coordinating and interpreting analytical testing data for TOC, conductivity, bioburden, and endotoxin in support of validation studies.
- Excellent technical writing skills with the ability to produce clear, accurate, and compliant validation documentation.
- Strong cross-functional collaboration and communication skills, with the ability to work effectively across engineering, manufacturing, and quality teams.
- Proven ability to independently manage timelines, prioritize tasks, and deliver validation projects on schedule.

Additional Skills & Qualifications

- B.S. or M.S. in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Biochemistry, or a related technical discipline.
- Experience working in biopharma or biologics manufacturing facilities with both stainless steel and single-use equipment.
- Hands-on familiarity with Clean-in-Place (CIP) and Steam-in-Place (SIP) systems and their integration into manufacturing operations.
- Experience in chromatography systems, skids, and tangential flow filtration (TFF) systems within a GMP environment.
- Experience as a Validation Engineer, Sr Validation Engineer, Equipment Validation Engineer, Cleaning Validation Engineer, CQV Engineer, C&Q Engineer, Validation Specialist, or Qualification Engineer.
- Ability to support continuous improvement initiatives in validation methodologies, documentation practices, and compliance processes.

Work Environment This role is fully onsite, working five days per week at a biopharmaceutical manufacturing facility in Oceanside, CA. The standard schedule is Monday through Friday, from 9:00 AM to 5:30 PM PT, supporting commercial-scale stainless steel and single-use manufacturing operations under cGMP conditions. You will work closely with multidisciplinary teams in a regulated environment that utilizes complex process equipment such as bioreactors, chromatography skids, TFF systems, autoclaves, and CIP/SIP systems, as well as analytical technologies for TOC, conductivity, bioburden, and endotoxin testing. The interview process typically includes two rounds: an initial virtual discussion followed by an onsite panel interview. The culture emphasizes collaboration, rigorous compliance, and continuous improvement in validation and manufacturing practices.
Job Type & Location
This is a Contract position based out of Oceanside, CA.
Pay and Benefits
The pay range for this position is $60.00 - $80.00/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)
Job Type & Location
This is a Contract position based out of Oceanside, CA.
Application Deadline
This position is anticipated to close on Nov 16, 2026.
Workplace Type
This is a fully onsite position in Oceanside,CA. 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 [email protected] 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.