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Title: Sr Process Engineer
Location: Middletown, VA (Travel to client sites may be required up to 100%, based on project demands and client expectations)
Schedule: 40 hours a week
Duration: 12 months
Start: ASAP
Reason: Growth
Most Important:
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.
Primary responsibilities include:
- 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
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
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