Validation Engineer

BEPC Inc. - Business Excellence Professional Consulting; Oceanside (CA); On-site; USD 103,000 - 117,000; Full time

Job summary

BEPC Inc. is actively seeking a Validation Engineer for our client site in Oceanside, CA. The role focuses on authoring, executing, and summarizing equipment qualification and cleaning validation activities in GMP manufacturing environments.

5‑day onsite schedule, 9:00 AM–5:30 PM PT, with a 24‑month W2 contract. The ideal candidate will have 8–10+ years of direct validation experience in cGMP biopharma, strong technical writing, and hands‑on expertise with CIP/SIP, IQ/OQ/PQ, and regulatory

Qualifications

• Bachelor of Science (B.S.) or Master of Science (M.S.) in Chemical Engineering or related technical discipline.
• 8–10+ years of direct validation engineering experience in a cGMP biopharmaceutical or biotechnology facility.
• Hands‑on experience with equipment validation, CIP/SIP systems, and strong technical writing.

Responsibilities

• Author, review, and execute IQ, OQ, and PQ protocols for manufacturing systems and equipment.
• Support validation activities across commercial stainless steel and single‑use facilities.
• Develop and execute cleaning validation protocols and sampling plans.
• Document validation activities and maintain accurate records.

Skills

Technical writing

Communication

Project management

Troubleshooting

Education

B.S./Bachelors in Chemical Engineering

M.S. in Chemical Engineering

Job description

BEPC is actively looking for a Validation Engineer in the Oceanside, CA area!

W2 Contract – 24 months, with possible extensions.

Benefits include medical, dental, vision, and life insurance.

Pay Rate: $75.00 – $85.11/hour – Determined based on experience

Work Model: Fully Onsite – 5 days per week

Work Schedule: Monday–Friday, 9:00 AM–5:30 PM PT

Work Location: Oceanside, CA 92056

Note: This is a W2 only role — C2C, C2H will not be considered.

Summary of the Position

BEPC is seeking a highly motivated Validation Engineer to join our client’s site in Oceanside, CA. This role will support the Validation Engineering team by authoring, executing, and summarizing equipment qualification and cleaning validation activities across commercial stainless steel and single-use manufacturing facilities.

The ideal candidate will bring extensive hands‑on experience with GMP manufacturing equipment, Clean-in-Place (CIP) and Steam-in-Place (SIP) systems, and strong technical writing and communication skills. This position focuses on ensuring equipment qualification and cleaning validation activities meet established quality and regulatory standards.

Main Duties and Responsibilities

Equipment Qualification and Protocol Execution

• Author, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for manufacturing systems and equipment.
• Support equipment qualification activities across commercial stainless steel and single‑use manufacturing facilities.
• Evaluate validation test results against established acceptance criteria.
• Resolve execution discrepancies through structured troubleshooting.
• Author protocol exceptions in collaboration with cross‑functional stakeholders.

Cleaning Validation and Verification

• Develop and execute Cleaning Validation (CV) and cleaning verification protocols.
• Develop and implement sampling plans and conduct visual inspections.
• Coordinate analytical testing and data evaluation, including:
• Total Organic Carbon (TOC).
• Conductivity.
• Endotoxin.
• Support validation activities involving CIP and SIP systems.

Documentation and Continuous Improvement

• Document validation activities and maintain accurate validation records.
• Prepare and summarize qualification and cleaning validation documentation.
• Support continuous improvement initiatives within validation processes.
• Collaborate with cross‑functional teams to address validation discrepancies and maintain project progress.

Regulatory Compliance and GMP Standards

• Ensure equipment qualification and cleaning validation deliverables comply with applicable industry and regulatory standards.
• Maintain alignment with established GMP requirements and the client's quality standards.

Main Qualifications

• Education: Bachelor of Science (B.S.) or Master of Science (M.S.) in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Biochemistry, or a related technical discipline.
• Experience: 8–10+ years of direct validation engineering experience within a current Good Manufacturing Practice (cGMP) biopharmaceutical or biotechnology manufacturing facility.
• Equipment Validation: Direct hands‑on experience authoring and executing equipment validation protocols involving:
• Bioreactors.
• Chromatography skids.
• Tangential Flow Filtration (TFF) systems.
• Autoclaves.
• Cleaning Validation: Direct hands‑on experience authoring and executing cleaning validation activities involving:
• Clean-in-Place (CIP) systems.
• Steam-in-Place (SIP) systems.
• Residue limits.
• Recovery studies.
• Technical Writing: Excellent technical writing skills, including the ability to prepare clear and accurate validation documentation.
• Communication and Collaboration: Strong verbal and written communication skills, with demonstrated ability to collaborate effective across functional teams.
• Project Management: Proven ability to independently manage timelines.
• Problem‑Solving: Ability to evaluate validation results, troubleshoot execution discrepancies, and coordinate resolutions with stakeholders.

About BEPC

BEPC Inc., founded in 2007, is a 100% employee‑owned company providing top‑tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.