Validation Engineer (Contractor)

Apollo Professional Solutions; Oceanside (CA); On-site; USD 124,000 - 179,000; Full time

Job summary

Apollopros seeks a Validation Engineer (Contract) to support equipment and cleaning validation in a regulated biopharmaceutical manufacturing environment in Oceanside, CA. The role is onsite, five days a week, with standard PT hours.

You will author and execute IQ/OQ/PQ protocols, perform data analysis, and ensure compliant documentation per cGMP. Strong hands-on validation experience and cross-functional collaboration are essential.

Qualifications

• Bachelor's or Master's degree in Chemical/Biomedical/Mechanical Engineering or related
• 8–10+ years of validation engineering in cGMP biopharma/manufacturing
• Proven experience authoring/executing Equipment Validation and Cleaning Validation protocols
• Hands-on experience with IQ/OQ/PQ and validated systems like bioreactors, CIP/SIP, and stainless/ single-use setups

Responsibilities

• Author, review, execute, and summarize IQ/OQ/PQ validation protocols for equipment and systems.
• Develop and execute Cleaning Validation protocols; coordinate sampling and data analysis.
• Ensure compliance with cGMP, generate audit-ready documentation, and support regulatory readiness.

Skills

Technical writing

Cross-functional collaboration

Problem solving

Analytical thinking

Education

Bachelor's or Master's in Chemical Engineering

Biomedical Engineering

Biochemistry/Mechanical Engineering

Tools

Bioreactors

Chromatography skids

TFF systems

Autoclaves

CIP/SIP systems

Single-use equipment

Stainless steel systems

Job description

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.