Project Engineer
Job Location:
Gaithersburg, MD - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
COMPANY DESCRIPTION:
A career here is life-enhancing.
At Syner-G we enable our people to build careers that impact positively on their quality of life. Through our expertise insight consulting and management skills we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful varied and thought-provoking work with a strategic emphasis a solutions-driven approach and significant real-world outcomes from science to delivery/success. To learn more about who we are and what drives us watch our company video here.
Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow we support them in their learning and we reward them in so many different return they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.
Syner-G was recently honored with BioSpaces prestigious Best Places to Work 2026 award for the third consecutive year along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees with a particular emphasis on culture career growth and development opportunities financial rewards leadership and innovation.
At Syner-G we recognize that our team members are our most valuable asset. Join us in shaping the future where your talents are valued and your contributions make a meaningful impact.
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 REQUIREMENTS
To 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
- Bachelors 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.
LEGAL STATEMENT:
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions including the recruiting hiring placement training availability promotion compensation evaluation disciplinary actions and termination of employment (if necessary) are made without regard to the employees race color creed religion sex pregnancy or childbirth personal appearance family responsibilities sexual orientation or preference gender identity political affiliation source of income place of residence national or ethnic origin ancestry age marital status military veteran status unfavorable discharge from military service physical or mental disability or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.
Required Experience:
IC
About Company
The world’s leading CMC & Regulatory Affairs solutions provider for biopharma. Consulting solutions in CMC 360, global regulatory affairs & medical writing.
