About this role
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
Responsibilities
- Ability to read and interpret electrical, mechanical, instrumentation, and control systems line diagrams and prints
- Familiarity with servicing of equipment consisting of boilers, chillers, air compressors, deionized water generation, HVAC, piping distribution systems, generators, GMP suite maintenance, and building maintenance/upkeep
- Support the daily Facilities and Engineering work flow through escorting and supervising contractors/vendors, performing equipment moves, handling equipment deliveries, transferring equipment/materials between offsite storage, and other tasks as assigned
- Perform corrective maintenance and emergency repairs to minimize equipment downtime.
- Follow Good Documentation Practices (GDP) and cGMP requirements when documenting maintenance activities.
- Support equipment purchases such as uncrating, moving, installing, and connecting required plant utilities to the point of use
- Troubleshoot mechanical, electrical, pneumatic, hydraulic, and process equipment failures.
- Work may include systems repairs/modifications encompassing HVAC, VFD’s, piping/plumbing, lighting, flooring, drywall, grounds, painting, and other areas that are not noted
- Ensure all maintenance activities are performed safely and in accordance with OSHA, environmental, and company safety requirements.
- Support shutdown activities, equipment relocations, facility projects, and capital improvement initiatives.
- Participate in the on-call rotation to support manufacturing and facility operations outside normal business hours.
- Maintain F&E owned areas and ability to perform work in accordance with site expectations and pharmaceutical industry standards
Qualifications
- 1-3 years minimum experience in pharmaceutical manufacturing, research, or equivalent highly regulated environment.
- Supported maintenance activities within utility areas, labs, and classified cleanrooms with following gowning procedures and safety protocols
- Supporting electrical/mechanical/facility installation projects
- Experience with BMS/EMS systems
- Experience using CMMS systems such as Blue Mountain, Maximo, Qualer, or equivalent
- Strong electrical and mechanical capabilities/aptitude
- Work collaboratively and productively across multiple site departments
- Associate degree in Mechanical Technology, Electrical technology, Mechatronics, or related technical discipline