Job Title: Validation EngineerJob Description

We are seeking a Validation Engineer to draft and review User Requirement Specifications (URS), perform equipment qualifications (IQ, OQ, PQ), execute process and cleaning validations, and generate and maintain validation documentation. The role involves troubleshooting and investigating deviations, supporting scale-up and technology transfer efforts, and coordinating with cross-functional teams to ensure compliance with cGMP standards.

Responsibilities

• Draft and review User Requirement Specifications (URS) for new and existing process equipment, ensuring alignment with manufacturing needs and regulatory standards.

• Plan, execute, and document qualification protocols (IQ, OQ, PQ) to verify equipment performance meets cGMP requirements and intended use.

• Identify critical process parameters, establish validation protocols, and conduct cleaning validations to maintain product quality and regulatory compliance.

• Prepare, review, and archive validation reports, SOPs, protocols, and related records to ensure clear traceability and audit readiness.

• Collaborate with cross-functional teams to diagnose equipment and process issues, implement corrective actions (CAPA), and address audit observations promptly.

• Work with manufacturing and development groups to optimize processes, facilitate seamless scale-up, and transfer validated methods across sites.

• Engage Quality, Process Development, and Manufacturing teams to meet project timelines, drive continuous improvement, and uphold cGMP standards.

Essential Skills

• Experience in validation engineering or a closely related field within a cGMP-regulated pharmaceutical or biotech environment (1–3 years).

• Foundational understanding of process validation, equipment qualification (IQ/OQ/PQ), and pharmaceutical manufacturing processes.

• Working knowledge of process validation and equipment qualification within a cGMP framework.

• Proficiency in drafting and reviewing validation documents (URS, SOPs, protocols, reports).

• Familiarity with deviation investigations, CAPA processes, and audit responses.

• Basic vendor management skills to evaluate and coordinate with external equipment/service providers.

• Competence in using data analysis tools and MS Office applications to track and report validation results.

Additional Skills & Qualifications

• Bachelor’s degree in engineering, Chemistry, or a related scientific discipline.

• Certifications related to GMP compliance, quality systems, or validation are preferred.

• Strong problem-solving and analytical abilities to identify and troubleshoot process and equipment issues.

• Excellent communication skills for collaboration with cross-functional teams (e.g., Quality, Manufacturing, Process Development).

• Detail-oriented mindset with a commitment to maintaining compliance and documentation accuracy.

• Ability to manage multiple tasks and projects under tight deadlines while ensuring quality and regulatory standards.

Work Environment

The role is based in a cGMP-regulated pharmaceutical or biotech environment, requiring collaboration with Quality, Manufacturing, and Process Development teams. The position involves the use of data analysis tools and MS Office applications to track and report validation results. The candidate must be able to manage multiple tasks and projects under tight deadlines while maintaining compliance and documentation accuracy.

Pay and Benefits

The pay range for this position is $100000.00 - $112000.00/yr.

On-Time Validation Deliverables:• Complete validation projects (IQ, OQ, PQ, cleaning validation) within designated timelines, achieving a target of (e.g., 95%) on-time completion.2. Compliance Rate:• Maintain (e.g., 98%+) adherence to cGMP standards, evidenced by minimal deviations or findings during internal and external audits.3. Deviation/CAPA Closure Efficiency:• Address and close deviations, audit observations, and CAPAs within (e.g., 30 days) of identification, ensuring timely resolution.4. Documentation Accuracy:• Achieve 100% accuracy in validation documentation (URS, protocols, SOPs, reports) with no major discrepancies identified during audits.5. Vendor Management Effectiveness:• Evaluate and coordinate with equipment/service vendors to meet project requirements, achieving a (e.g., 95%) on-time and within-budget vendor performance rate.

Workplace Type

This is a fully onsite position in Torrance,CA.

Application Deadline

This position is anticipated to close on Mar 10, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.