POSITION OVERVIEW:We are seeking experienced Project Engineers to support commissioning and qualification activities within GMP-regulated biopharmaceutical manufacturing environments. This role will primarily focus on the development, execution, and documentation of Installation Qualification (IQ) protocols for bioreactors, media hold tanks, and associated process systems. The ideal candidate will possess hands-on CQV experience and a strong understanding of equipment qualification, engineering documentation, and GMP compliance requirements.
WORK LOCATION:Travel to client sites may be required up to 100%, depending on project needs and client expectations.
KEY RESPONSIBILITIES:(This list is not exhaustive and may be supplemented or adjusted as needed.)
- Develop, review, and execute Installation Qualification (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 activities 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.
- Ensure all work is performed in compliance with site safety standards, quality requirements, and regulatory expectations.
QUALIFICATIONS AND REQUIREMENTSTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education
- Bachelor's Degree in Engineering, Life Sciences, Biotechnology, or a related technical discipline.
Technical Experience
- 3+ years of CQV, Validation, Engineering, or Technical Operations experience within 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.
- Experience utilizing electronic validation systems such as Kneat or similar validation platforms is preferred.
Knowledge, Skills, and Abilities
- 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 a high attention to detail.
- Excellent verbal and written communication skills.
- Ability to work independently and collaboratively within cross-functional teams.
ESSENTIAL FUNCTIONS:Physical Demands
: The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.
Work Environment
: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.
TOTAL REWARDS PROGRAM:We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere." However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.
Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.
