Major accountabilities:

• Provide technical troubleshooting throughout equipment lifecycle (startup, qualification, commercial production)
• Perform investigations / deviations from an engineering perspective to allow for timely closure of deviations and CAPAs
• Lead or contribute to process equipment and utility improvement projects
• Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications and update as needed
• Write/revise engineering documents for operation of various production systems
• Ensure compliance with industrial standards and GMP guidelines
• Develop project cost estimation and value improvement review
• Perform GMP risk assessments
• Manage technical / engineering changes through site change control process
• Participate in preparation of calibration/maintenance risk assessments for new equipment
• Create/execute Design Qualification (DQ), Installation and Operational Qualification (IOQ), and Performance Qualification (PQ) protocols
• Support internal and external audits

The pay range for this position at commencement of employment is expected to be between $85,400 to $158,600/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Minimum Requirements:

• B.S. degree in Chemical, Electrical, Mechanical or Nuclear Engineering, or related technical field, with a 3+ years experience providing automation, engineering, or equivalent support within the pharmaceutical, biotechnology, or related industry
• Proven skills in project management and problem solving
• Exceptional time management, planning, organizational, negotiating and influencing skills
• Highly self-motivated with a willingness to assume responsibilities and take ownership for work
• Must be able to adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (For example: OSHA, FDA, EMEA, HS&E, etc.)
• Proficient computer skill utilizing MS Office suite applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS) and similar GMP systems
• Ability to climb ladders and lift up to up to 50 lbs.
• Aseptic Filling line, packaging operation experience is preferred
• Training/experience in radiochemistry or radio safety is desirable