Job Description: CQV Engineer

We are seeking forward-thinking and ambitious engineers looking to accelerate their careers in the pharmaceutical, biotechnology, and medical device industries. This role offers the opportunity to collaborate with industry subject matter experts and thought leaders while consulting with some of the largest companies in the Life Sciences sector.

We are hiring multiple CQV Engineers with 5+ years of experience in project engineering and validation to support a long-term expansion project at a pharmaceutical facility in the Greater Los Angeles area. Candidates with a broad range of validation expertise are encouraged to apply.

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Responsibilities

Project Engineering Support

· Develop User Requirement Specifications (URS), Functional Specifications, and Design Specifications

· Author SOPs and manage project-related change (MOC)

· Support FMEA and HAZOP activities

· Perform risk and gap assessments

· Prepare project closeout documentation and turnover packages

· Manage project change requests

· Collaborate with client and engineering/architecture partners on conceptual, basic, and detailed design reviews

Construction Activities

· Develop and oversee Safety Management Plans, including Job Hazard Analyses, Lockout/Tagout Plans, Hot Work Permits, and Detour Plans

· Coordinate disruptive construction activity requests and plant-wide communications

· Create and maintain Quality Management Plans and Construction Control Plans

· Support installation, operational, and performance qualification activities

· Conduct risk assessment, change control, and quality audits

Validation Support

· Perform equipment IQ, OQ, and PQ

· Lead process, cleaning, and facility validation

· Conduct validation of critical facility systems and software, including data management and process control systems

· Compile and finalize validation protocols and reports

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Qualifications

· Bachelor’s degree or higher in Engineering, Life Sciences, or a related discipline (e.g., Mechanical Engineering, Chemical Engineering, Chemistry, Biology)

· 5+ years of relevant experience in FDA-regulated industries

· Local to the Los Angeles area (no travel expenses provided)

· Strong knowledge of cGMP and regulatory standards

· Experience with pharmaceutical process equipment and instrumentation

· Proficiency in project engineering and construction-related activities

· Expertise in equipment, process, cleaning, facility, and software validation

· Excellent problem-solving and troubleshooting skills

· Strong leadership, project management, and client relationship skills

· Proficient in Microsoft Office (Word, Excel, PowerPoint, MS Project, Visio)

· Exceptional technical writing, review, and analytical skills

· Knowledge of good documentation practices (GDP)