View All Jobs 117694

Staff Process Engineer - Remote Eligible

Lead end-to-end capital projects from concept to validation for biotech manufacturing processes
Norton, Massachusetts, United States
Expert
4 days ago
Syner-G BioPharma Group

Syner-G BioPharma Group

Provides integrated CMC, regulatory, and product development consulting services to accelerate and de-risk biopharmaceutical programs from preclinical through commercialization.

1 Similar Job at Syner-G BioPharma Group

Staff Process Engineer

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.

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.

Syner-G is seeking a Staff Process Engineer with 10–15 years of experience to provide senior-level technical leadership in the design, optimization, and automation of manufacturing and laboratory processes. This role is responsible for driving complex process engineering initiatives, leading large-scale equipment integration and automation projects, and shaping long-term process strategies for client programs. The Staff Process Engineer will serve as a subject matter expert, guiding cross-functional teams, mentoring engineers, and ensuring robust, scalable, and efficient processes across development and manufacturing environments.

Travel to client sites may be required up to 100%, based on project demands and client expectations.

Key Responsibilities

  • Provide process engineering support for capital projects from concept through design, procurement, construction, startup, commissioning and validation.
  • Develop and maintain process documentation, including PFDs, P&IDs, equipment specifications, process descriptions, and equipment sizing calculations.
  • Develop User Requirements Specifications (URS) and functional specifications for process equipment and systems.
  • Support process equipment procurement including technical bid evaluations, submittal review, and vendor coordination.
  • Lead and/or support Factory Acceptance Testing (FAT) and ensure equipment meets process and operational requirements.
  • Provide on-site support for Site Acceptance Testing (SAT), commissioning, startup, and system tuning.
  • Perform functional verification, resolve startup issues, and manage functional specification (FS) redlines and updates.
  • Lead commissioning, qualification, and startup activities for process equipment.
  • Troubleshoot process and equipment issues during startup and early operations to achieve performance, yield, and reliability targets.
  • Ensure compliance with GMP requirements and support operational readiness activities including SOP development and operator training.

Qualifications and Requirements

Education

  • BS or MS in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, or a related technical field preferred.

Experience

  • 10-15 years of experience in process engineering within biotech, pharmaceutical, or advanced manufacturing environments.
  • Hands-on experience supporting capital projects and facility startups.
  • Strong experience with process equipment procurement activities including submittal review, FAT, SAT, and commissioning.

Technical Skills

  • Direct experience with thin film evaporation systems.
  • Direct experience with commercial scale spray drying operations and equipment, PSD-1 or larger preferred.
  • Strong knowledge of GMP manufacturing requirements and regulatory expectations.
  • Strong understanding of process engineering fundamentals, including mass/energy balances, process control principles, and equipment design.
  • Ability to interpret and develop P&IDs, equipment drawings, and automation logic.
  • Data analysis skills, including statistical methods, modeling tools, and engineering software.
  • Excellent communication, leadership, and project management skills.
  • Ability to manage multiple complex priorities in a fast-paced, technically demanding environment.

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.

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.

+ Show Original Job Post
























Staff Process Engineer - Remote Eligible
Norton, Massachusetts, United States
Engineering
About Syner-G BioPharma Group
Provides integrated CMC, regulatory, and product development consulting services to accelerate and de-risk biopharmaceutical programs from preclinical through commercialization.