Sr. Process Engineer en Syner-G BioPharma Group

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:

• Bachelor’s 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
• 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.

Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.