Validation Engineer

Spectraforce Technologies, Inc.; Oceanside (CA); Presencial; USD 96 000 - 131 000; Tempo integral

Resumo da oferta

Spectraforce Technologies, Inc. seeks an experienced Validation Engineer (Contractor) to support the Validation Engineering team at the Oceanside facility, handling authoring, executing, and summarizing qualification and cleaning validation activities for GMP manufacturing systems.

The ideal candidate has hands-on GMP equipment validation experience, CIP/SIP systems, and strong technical writing with cross-functional collaboration skills to enable timely, compliant records over a 24-month

Qualificações

• Education: B.S. or M.S. in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Biochemistry, or a related technical discipline.

Responsabilidades

• Author, review, and execute qualification protocols (IQ, OQ, PQ) for systems and equipment.
• Develop and execute Cleaning Validation (CV) and cleaning verification protocols, including sampling plans, inspections, and data coordination (TOC, conductivity, bioburden, endotoxin).
• Evaluate validation test results against acceptance criteria and resolve discrepancies with cross-functional teams.
• Support continuous improvement in validation processes and maintain records.

Conhecimentos

GMP validation

IQ/OQ/PQ protocols

CIP/SIP validation

Analytical data coordination

Technical writing

Cross-functional collaboration

Timeline management

Formação académica

B.S./M.S. in Chemical Engineering / Biomedical Engineering / Mechanical Engineering / Biochemistry

Descrição da oferta de emprego

Position Title: Validation Engineer

Work Location: 4038 Avenida De La Plata, Oceanside, CA 92056

Assignment Duration: 24 months

Work Schedule: Monday through Friday, 9 AM to 5:30 PM PT

Work Arrangement: Onsite

Position Summary:

• We are seeking an experienced Validation Engineer (Contractor) to support the Validation Engineering team at the Oceanside manufacturing facility. In this role, you will be responsible for authoring, executing, and summarizing equipment qualification and cleaning validation activities supporting both commercial stainless steel and single-use manufacturing facilities.
• The ideal candidate brings hands-on experience with GMP manufacturing equipment, Clean-in-Place (CIP)/Steam-in-Place (SIP) systems, and strong verbal and written communication skills.

Key Responsibilities:

Protocol Authoring & Execution

• Author, review, and execute qualification protocols (IQ, OQ, PQ) for systems and equipment.
• Develop and execute Cleaning Validation (CV) and cleaning verification protocols, including sampling plans, visual inspections, and analytical test data coordination (e.g., TOC, conductivity, bioburden, and endotoxin).
• Evaluate validation test results against defined acceptance criteria, resolve execution discrepancies via structured troubleshooting, and author protocol exceptions with cross-functional stakeholders.
• Support continuous improvement in validation processes.
• Document validation activities and maintain records.

Regulatory Compliance & GMP Standards

• Ensure all qualification deliverables are in compliance with industry and regulatory standards, and the organization's quality standards.

Qualification & Experience:

• Education: B.S. or 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 cGMP biopharmaceutical or biotechnology manufacturing facility.
• Direct hands-on experience authoring and executing both Equipment Validation (bioreactors, chromatography skids, TFF systems, autoclaves) and Cleaning Validation (CIP/SIP, residue limits, recovery studies).

Soft Skills:

• Excellent technical writing, cross-functional collaboration, and communication skills.
• Proven ability to independently manage timelines