Sr. Process Engineer

Syner-G

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profile Job Location:

Middletown, DE - 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:

We are seeking a Sr. Process Engineer with a strong background in mechanical or manufacturing engineering and hands-on experience in automated manufacturing environments preferably within the life sciences or biopharma industry. The ideal candidate will have demonstrated expertise in line layouts fixture design 3D printing and project management with a preference for experience in high-speed fill-finish lines and filling and capping equipment (though not essential). Familiarity with PLCs and HMIs is required though this is not a controls engineering role. Proficiency in AutoCAD and SolidWorks is essential.

WORK LOCATION:

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

KEY RESPONSIBILITIES:

  • Lead and support process engineering activities including design development and optimization of automated manufacturing systems
  • Develop and implement line layouts and custom fixtures to support manufacturing efficiency and scalability
  • Apply 3D printing technologies for prototyping and fixture development
  • Manage small to mid-sized engineering projects ensuring cross-functional collaboration and effective communication
  • Support commissioning and qualification of facilities utilities and equipment
  • Assist with technology transfer process development and validation activities
  • Conduct risk assessments and feasibility reviews to ensure compliance with manufacturing and regulatory requirements
  • Provide technical support for lifecycle management scale-up and continuous improvement initiatives
  • Collaborate with vendors and third-party contractors to support project execution and process optimization
  • Ensure adherence to cGMP FDA regulations and industry standards

QUALIFICATIONS & REQUIREMENTS:

Education:

  • Bachelors degree in Mechanical Engineering Manufacturing Engineering or a related technical field

Technical Experience:

  • 4 to 7 years of engineering experience in automated manufacturing preferably in life sciences or biopharma
  • Experience with high-speed fill-finish lines and filling/capping equipment is a plus

Knowledge Skills and Abilities:

  • Proficient in AutoCAD and SolidWorks Familiarity with PLCs and HMIs Experience with cGMP manufacturing in FDA-regulated environments
  • Knowledge of cGxP quality systems and applicable regulatory standards
  • Proficient in MS Office MS Project and Visio Knowledge Skills and Abilities: Strong project management and cross-functional communication skills
  • Innovative problem-solving and technical analysis capabilities
  • Ability to work hands-on in a fast-paced regulated environment
  • Willingness to travel to client sites as needed

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:

Senior 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

  • Lean Manufacturing
  • Six Sigma
  • Distributed Control Systems
  • Continuous Improvement
  • Process Improvement
  • Minitab
  • Root cause Analysis
  • Process Engineering
  • cGMP
  • Kaizen
  • Programmable Logic Controllers
  • Manufacturing

About Company

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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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