Sr. Process Engineer

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

Additional Information

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. To learn more about who we are and what drives us, watch our company video here . 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 ways. In 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 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. For more information, visit www.Synergbiopharma.com 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.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at synerg? Share your experience