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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 industry. The ideal candidate will have demonstrated expertise in engineering gap assessment, 2D drafting, 3D modeling, and equipment design and installation, with a preference for experience in fill-finish lines and filling, capping, and labeling equipment. Familiarity with PLCs and HMIs is required, though this is not a controls engineering role. Proficiency in AutoCAD, SolidWorks, and the MS Office suite (Word, Excel, Outlook, SharePoint) 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
• Deliver line layouts and custom fixtures for modification of existing equipment and manufacturing lines
• Generate diagrams, URS, SOPs, and Work Instructions for specification, procurement, installation, and operation of manufacturing equipment
• Effectively communicate site, equipment, and product requirements with vendors and third-party contractors to support project execution
• Manage small to mid-sized engineering projects, ensuring cross-functional collaboration and effective communication between engineering, automation, Quality, and Validation teams
• Support CQV as SME for facilities, utilities, equipment, and process
• Conduct risk assessments and feasibility reviews to ensure compliance with manufacturing and regulatory requirements
• 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

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 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.