Project Engineer

Syner-G BioPharma Group; Gaithersburg (MD); In loco; USD 110.000 - 150.000; Tempo pieno

Vantaggi offerti da questo lavoro

Market-competitive base salary

Annual incentive plan

Robust benefits

Career development opportunities

Generous PTO

Descrizione del lavoro

Syner-G BioPharma Group is seeking experienced Project Engineers to support IQ QCV activities in GMP biopharma manufacturing environments. You will develop and execute IQ protocols for bioreactors, media tanks, and utilities, ensuring installation aligns with P&IDs and engineering specs.

Your role includes field walkdowns, document reviews, and collaboration with Engineering, Manufacturing, QA, Validation, and vendors to ensure turnaround readiness and regulatory readiness.

Competenze

• 3+ years of CQV/Validation/Engineering experience in GMP environments.
• Experience developing/executing IQ protocols for process equipment.
• Familiarity with GMP documentation, GDP, and regulatory requirements.

Mansioni

• Develop, review, and execute IQ protocols for bioreactors and process equipment.
• Verify installation against P&IDs and vendor data.
• Perform field walkdowns and inspections to ensure compliance.
• Review turnover packages, certifications, and manuals.
• Identify and resolve qualification discrepancies and deviations.
• Support system turnover and qualification readiness with cross-functional teams.

Conoscenze

CQV methodologies

Equipment qualification

GMP/GDP knowledge

Technical writing

Formazione

Bachelor's Degree in Engineering or Life Sciences

Strumenti

Kneat

Descrizione del lavoro

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 ways. In 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 BioSpace's 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.

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

• 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.

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.

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars.

• a market competitive base salary
• annual incentive plan
• robust benefit offerings
• ongoing recognition and career development opportunities
• generous flexible paid time off program
• company-paid holidays
• flexible working hours
• fully remote work options for most positions
• 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 employee’s 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.