Engineer V in San Diego

DEPARTMENT: Professional Service Operations

STATUS: Full Time

LOCATION: Varies Between Remote or at a Client Site in the San Diego, CA area

cGMPnow accelerates Next Generation Therapies to patients by providing GxP Manufacturing & QC Laboratory Equipment, GxP Computerized Systems, Commissioning & Qualification, and Procurement services using project‑dedicated expert resources.

With our unique project delivery methodology and owner‑focused involvement, we bring new products to the market faster by providing cGMP systems faster.

The Engineer will provide process, equipment and project engineering and, at times, project management and business development functions. Overall this role will lead and support development and implementation process concepts and designs on technically complex capital projects for the FDA & EU regulated Advanced Therapeutic industries. This person must be an energetic, self‑motivated, organized and innovative individual who shall possess the skills required to successfully support and execute project tasks and deliverables, be a collaborative team player, and have a strong drive to deliver results.

This role covers engineering for complex cGMP manufacturing and lab facilities. This engineer may lead projects, ensuring timely and budget‑conscious completion through planning, resource management, budget oversight, progress monitoring, and stakeholder communication. The engineer may also assist with proposal development, business development, and strategic planning, including opportunity identification, proposal preparation, client engagement, and project evaluation.

Salary Compensation Range: $145,000 - $175,000 annual

Potential Commission Compensation Range: $0-$50,000+ annual

This position is eligible for healthcare benefits with the employee base premiums 100% paid for by the company, enrollment in a retirement savings plan with company contributions, company matching of charitable contributions, profit sharing and is eligible for paid time off. Training, conferences and professional registration dues are eligible for reimbursement.

Please note that the salary information is a general guideline only. Other factors such as (but not limited to) scope and responsibilities of the position, candidate's work experience, education/ training, key skills as well as market and business considerations when extending an offer.

Must have excellent planning skills, be highly organized and detail oriented, able to support multiple projects simultaneously and able to adapt to changing environments and priorities. Must be a self‑starter with the ability to work productively and meet benchmarks and goals in a timely fashion. Strong interpersonal communication and organizational skills are required.

B.S. Degree in Chemical, Biological, Biopharmaceutical or similar engineering degree required

6+ years total experience in GMP-regulated industry

4+ years experience in process design and engineering project management (or PM support capacity) in Pharmaceutical, Biopharmaceutical and/or Biotechnology industries

Experience and working knowledge of cGMP compliance

Knowledge of FDA, EMA, and other pharmaceutical regulatory standards and requirements

Knowledge and application of PIC/S, ISPE Baseline & Good Practice Guides and ASME BPE

Knowledge and experience with manufacturing process for Advanced Therapeutics Medicinal Products (ATMPs), such as autologous & allogeneic cell therapy, gene therapy, viral vector, stem cells, mRNA, and plasmid modalities

Knowledge and experience with equipment for manufacturing cGMP products (i.e. fermentors, bioreactors, mixers, pumps, chromatography, TFF, spray dryers, isolators, and vial/bag fillers)

Knowledge and experience with cGMP process utility and support operations (i.e. Process Gas Systems, WFI, Clean Steam Generators, Autoclaves, CIP Skids, Cleanroom HVAC, and QC laboratory equipment)

Knowledge of biosafety and containment control strategies, and applying these in a Risk Assessment

Ability to lead a small project entirely or area of a large project from an engineering perspective

Excellent verbal, written…