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Description
Job Purpose:
The Senior Engineering Associate provides technical and engineering support to the Manufacturing Science & Technology (MS&T) group, with primary responsibility for maintaining and controlling facility and engineering CAD drawings, supporting cleanroom construction activities, and assisting with capital and site improvement projects. This role serves as a key resource for engineering documentation, facility modifications, equipment installations, and project execution while ensuring compliance with cGMP requirements and internal quality standards. The position collaborates closely with Engineering, Validation, Quality, Manufacturing, and external contractors to support facility reliability, expansion initiatives, and operational excellence.
Essential Duties And Responsibilities
- Maintain, revise, and control facility, utility, process, and equipment CAD drawings in accordance with document control procedures.
- Develop and update engineering drawings, layouts, P&IDs, equipment arrangements, and as-built documentation for facility and process changes.
- Support cleanroom construction, renovation, and expansion projects, including coordination with contractors, vendors, and internal stakeholders.
- Assist with planning, execution, and closeout of capital projects, facility upgrades, and equipment installations.
- Participate in project design reviews and provide technical input for facility and process improvements
- Participate in the planning, development, and execution of engineering and process improvement initiatives
- Assist with the design, fabrication and integration of prototype components, tooling, and equipment
- Assist with procurement, installation, commissioning, and startup activities for new equipment and systems.
- Assist in troubleshooting activities across the facility
- Participate with preventative maintenance strategies and assist in maintaining plant equipment
- Assist with procurement, installation, and commissioning of new equipment
- Maintain engineering records, project files, and technical documentation in accordance with company procedures.
- Participate in contractor management activities, including scheduling, oversight, and verification of completed work.
- Develop, execute and document process development and validation protocols
- Prepare and revise technical documentation (SOPs, protocols, reports, change controls)
- Ensure all stability equipment operations comply with cGMP and internal procedures
- Oversee calibration and validation activities for stability chambers
- Maintain inventory of stability equipment, spare parts and critical components
- Oversee equipment qualification and requalification activities for stability chambers and related systems
Requirements
Experience:
- 5-7 years Pharmaceutical and/or Manufacturing experience
- Proficient in Microsoft Office Suite with a strong knowledge in Word and Excel
- Highly organized with the ability to manage multiple projects and changing priorities
- Ability to work well independently or with a team
- Advanced proficiency with AutoCAD and/or other CAD software required.
- Experience supporting facility, utility, cleanroom, or capital construction projects preferred.
- Willingness to participate in ongoing training and professional development opportunities.
- Strong understanding of facility systems, equipment layouts, and engineering drawing standards.
- Possess a strong attention to detail
- Knowledge of cGMP plant operations and scale-up is desired
- The ability to motivate and influence others, thinks globally and leverages diversity
- The ability to effectively manage oneself, demonstrates integrity, be productive under pressure, and achieve development goals
- Willingness to participate in training and gain other education and or certifications as needed
Working Conditions / Physical Requirements
- Position requires bending (desk to floor), lifting (up to 15 lbs.), corrected vision (20/20), standing, hearing, sitting, typing, and walking
- Ability to work in cleanroom environments, including gowning requirements
