Project Engineer

Syner-G•Gaithersburg, MD

About The Position

Syner-G is seeking experienced Project Engineers to support commissioning and qualification (CQV) activities in GMP-regulated biopharmaceutical manufacturing environments. The role primarily focuses on developing, executing, and documenting Installation Qualification (IQ) protocols for bioreactors, media hold tanks, and associated process systems. Candidates should have hands-on CQV experience and a strong understanding of equipment qualification, engineering documentation, and GMP compliance. Travel to client sites may be required up to 100%, depending on project needs and client expectations. The role involves collaboration with Engineering, Manufacturing, Quality Assurance, Validation, and equipment vendors, and maintaining qualification documentation to support system turnover, regulatory inspections, and audits. Syner-G describes its total rewards program as including competitive base salary, an annual incentive plan, benefits, recognition, career development, flexible paid time off, company-paid holidays, flexible working hours, and fully remote work options for most positions. The company is unable to sponsor employment visas at this time.

Requirements

Bachelor's degree in Engineering, Life Sciences, Biotechnology, or a related technical discipline.
At least 3 years of CQV, Validation, Engineering, or Technical Operations experience in biotechnology, pharmaceutical, or other GMP-regulated manufacturing environments.
Demonstrated experience developing and executing IQ protocols for process equipment.
Experience qualifying bioprocess equipment such as bioreactors, media preparation systems, media hold tanks, process vessels, and associated utility systems.
Experience reviewing engineering documentation, including P&IDs, equipment specifications, vendor packages, and turnover documentation.
Familiarity with commissioning, qualification, and validation lifecycle activities.
Working knowledge of GMP documentation practices, Good Documentation Practices (GDP), and regulatory compliance requirements.
Strong understanding of CQV methodologies and equipment qualification principles.
Knowledge of upstream bioprocess manufacturing systems and related equipment.
Ability to interpret engineering drawings, P&IDs, and technical documentation.
Strong technical writing, documentation, and organizational skills.
Ability to manage multiple priorities in a fast-paced project environment.
Strong analytical and problem-solving abilities with attention to detail.
Excellent verbal and written communication skills.
Ability to work independently and collaboratively within cross-functional teams.

Nice To Haves

Experience using electronic validation systems such as Kneat or similar platforms.

Responsibilities

Develop, review, and execute IQ protocols for bioreactors, media hold tanks, and associated process equipment.
Verify equipment installation against approved P&IDs, engineering specifications, vendor documentation, and design drawings.
Perform field walkdowns, equipment inspections, and installation verification to ensure compliance with project and regulatory requirements.
Confirm proper installation and identification of instrumentation, utilities, piping components, and process equipment.
Review vendor turnover packages, material certifications, calibration records, equipment manuals, and supporting qualification documentation.
Identify, document, and support resolution of qualification discrepancies, punch list items, and deviations.
Collaborate with Engineering, Manufacturing, Quality Assurance, Validation, and equipment vendors to support system turnover and qualification readiness.
Support commissioning and qualification activities in accordance with GMP, GDP, and site validation procedures.
Maintain accurate and complete qualification documentation to support regulatory inspections and audits.
Communicate project status, execution risks, and qualification progress to stakeholders and project teams.
Perform work in compliance with site safety standards, quality requirements, and regulatory expectations.