Current Locations: Michigan & Massachusettes
Facilities and Utility Engineer:
AM is looking for experienced personnel with knowledge of GEP and GMP facilities and utilities systems and can manage and lead the startup and commissioning of such systems.
This person will be integrated into the early stages of the site buildouts to establish all aspects of the engineering lifecycle and facilities needs including the startup, commissioning, validation, biopharma manufacturing facility.
This individual will be a key member of AM and lead a team responsible for delivering the facilities GEP (Non-Impact) and GMP (Indirect & Direct) utilities and systems.
- Lead the startup, and commissioning of GEP systems such as:
- CRAC units
- HVAC chiller
- Desiccant Dehumidification system (Munters unit)
- HVAC distribution and VAVs (62)
- Exhaust fans
- pressure control strategies
- Building Automation System – functionality by system + all alert/alarm points
- Electrical power systems: Normal
- Standby generator
- Emergency & UPS
- PH neutralization and transfer lift station
- Compressed air system
- WFI/(RODI) generation and distribution systems
- Tempered water system and emergency showers and eye washes
- GMP Systems:
- N2 system (verify via P&ID)
- Process Chillers
- Clean Steam Generator
- Parts washer
- BSC, Fumehoods, LFHs
- Knowledge of Engineering Lifecycle Documents (Resign Reviews, SATs, FATs, Installation and Operation commissioning and qualification
- Hands-on experience operating these systems and equipment
Qualifications, Skills, And Experience
- Bachelor’s degree or equivalent in Engineering, Science, or related discipline
- 5+ years of experience working in a GMP manufacturing facilities role.
- Experience using building monitoring systems (BMS), Environmental Monitoring Systems (EMS), Quality Management Systems (QMS), Familiarity with GMP clean utilities including HVAC, high purity water and gas systems is a must.
- Experience commissioning, validating and startup of biopharma manufacturing facility.
- Ability to effectively communicate with all levels within the organization
- Ability to build collaborative relationships with colleagues and clients
- Demonstrated effectiveness in a dynamic, fast-paced, and ever-changing environment.
- Able to deal with pressure, take on challenging projects, manage competing priorities, and anticipate problems in advance