Validation Engineer (Contractor)

Validation Engineer (Contract) – Equipment & Cleaning Validation
Location: Oceanside, CA
Schedule: Onsite, 5 days per week (Monday-Friday)
Hours: 9:00 AM - 5:30 PM PT
Employment Type: Contract
Join a High-Impact Biopharmaceutical Manufacturing Team
We are seeking a highly experienced Validation Engineer to support critical Equipment Validation and Cleaning Validation initiatives within a regulated biopharmaceutical manufacturing environment. This role offers the opportunity to work on complex commercial manufacturing systems, contributing directly to compliance, operational excellence, and product quality.

The ideal candidate will have extensive hands-on experience in cGMP validation, including equipment qualification, cleaning validation, and the validation of stainless steel and single-use manufacturing systems. Strong technical writing, problem-solving, and cross-functional collaboration skills are essential for success in this role.
Key Responsibilities Equipment Qualification & Validation

• Author, review, execute, and summarize validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Support qualification activities for manufacturing equipment and systems used in commercial biopharmaceutical production.
• Evaluate validation data, verify compliance with acceptance criteria, and prepare validation reports and supporting documentation.
• Investigate protocol discrepancies, perform root cause analysis, and develop protocol exceptions and corrective actions in collaboration with cross-functional teams.
• Identify opportunities to improve validation processes and execution efficiency.

Cleaning Validation

• Develop and execute Cleaning Validation (CV) and cleaning verification protocols.
• Create sampling plans and coordinate validation testing activities, including:
  • Total Organic Carbon (TOC)
  • Conductivity
  • Bioburden testing
  • Endotoxin testing
  • Visual inspection assessments
• Support cleaning validation studies, including recovery studies, residue limit evaluations, and qualification of Clean-in-Place (CIP) and Steam-in-Place (SIP) systems.
• Analyze and interpret cleaning validation data to ensure compliance with established requirements.

Compliance & Documentation

• Ensure all validation activities are performed in accordance with cGMP regulations, site quality standards, and applicable industry guidelines.
• Maintain accurate, audit-ready validation documentation and records.
• Collaborate with Manufacturing, Quality Assurance, Engineering, and other stakeholders to support successful project execution and regulatory readiness.

Required Qualifications Education

• Bachelor's or Master's degree in:
  • Chemical Engineering
  • Biomedical Engineering
  • Mechanical Engineering
  • Biochemistry
  • Or a related technical discipline

Experience

• 8-10+ years of validation engineering experience in a cGMP biopharmaceutical, biotechnology, or pharmaceutical manufacturing environment.
• Proven experience authoring and executing both Equipment Validation and Cleaning Validation protocols.
• Strong hands-on experience with:
  • Bioreactors
  • Chromatography skids
  • Tangential Flow Filtration (TFF) systems
  • Autoclaves
  • CIP/SIP systems
  • Single-use manufacturing equipment
  • Stainless steel process systems
• Knowledge of qualification lifecycle methodologies and validation best practices.

Key Skills

• Excellent technical writing and documentation skills.
• Strong verbal communication and cross-functional collaboration abilities.
• Demonstrated ability to independently manage multiple priorities and meet project deadlines.
• Strong analytical and troubleshooting capabilities within a regulated manufacturing environment.

Preferred Candidate Profile
The successful candidate is a self-directed validation professional who thrives in a fast-paced biopharmaceutical manufacturing setting and brings deep expertise in equipment qualification, cleaning validation, compliance, and GMP operations. This is an excellent opportunity to apply advanced validation knowledge while supporting critical manufacturing and quality objectives.

Keywords: Validation Engineer, Equipment Validation, Cleaning Validation, IQ OQ PQ, cGMP, Biopharmaceutical Manufacturing, Biotechnology, CIP, SIP, Qualification Engineer, Process Validation, TFF Systems, Bioreactor Validation, Pharmaceutical Validation, Compliance, Quality Systems, Oceanside CA Jobs.