Senior Engineering Associate (MS&T)

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.
• Aid in 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.
• Aid in the design, fabrication and integration of prototype components, tooling, and equipment.
• Aid in procurement, installation, commissioning, and startup activities for new equipment and systems.
• Aid in troubleshooting activities across the facility.
• Participate in preventative maintenance strategies and assist in maintaining plant equipment.
• Aid in 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.

Experience

• 5-7 years Pharmaceutical and/or Manufacturing experience
• Proficient in Microsoft Office Suite with a strong knowledge in Word and Excel
• Hightly 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, think globally and leverage diversity
• The ability to effectively manage oneself, demonstrate integrity, be productive under pressure, and achieve development goals
• Willingness to participate in training and gain other education and/or certifications as needed