Sr. Process Engineer

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, Solid Works, and the MS Office suite (Word, Excel, Outlook, SharePoint) is essential.

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

• 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

• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a related technical field

• 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 Solid Works
• 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
• 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

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.

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.

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…