Staff Process Engineer

Syner-G

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profile Job Location:

Norton, OH - USA

profile Monthly Salary: Not Disclosed
Posted on: 9 hours ago
Vacancies: 1 Vacancy

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.

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.

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POSITION OVERVIEW:

Syner-G is seeking a Staff Process Engineer with 1015 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.

WORK LOCATION:

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

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented or changed as necessary.)

  • 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.

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 employers. 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:

Staff IC

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 pat...
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Key Skills

  • Computer Science
  • Docker
  • Kubernetes
  • Python
  • VMware
  • C/C++
  • Go
  • System Architecture
  • gRPC
  • OS Kernels
  • Perl
  • Distributed Systems

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The world’s leading CMC & Regulatory Affairs solutions provider for biopharma. Consulting solutions in CMC 360, global regulatory affairs & medical writing.

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