Pharmaceutical Manufacturing Equipment Engineer
The Fountain Group
· This position reports to the Associate Director of Engineering Technical Services supporting GMP clinical manufacturing. Responsible for maintaining reliable equipment performance in one manufacturing area at the Gaithersburg Clinical Manufacturing facilities including cell culture, purification, and support systems.
· Subject Matter Expert (SME) manufacturing equipment in assigned area
· Resolves daily operational issues in assigned area
· Performs troubleshooting, maintenance, and process performance optimization
· Installs or replaces components and equipment. Supports shutdown and return to service activities
· Writes, tracks, and executes SAP work orders, and creates and revises Preventative Maintenance plans
· Coordinates maintenance activities with Facilities / Coordinates service contracts and work of outside vendors.
· Obtains quotes and purchases spare parts and equipment, and adds parts to the SAP inventory system
· Monitors equipment performance. Identifies equipment issues and helps develop technical solutions
· Determines process requirements. Helps design, install, and commission new processes and equipment
· Writes cGMP documentation (SOPs, MPRs, protocols, etc.)
· Writes other documentation including: user requirements, specifications, protocols, HECPs, drawings, and reports
· Performs quality/safety investigations, and risk evaluations. Owns and executes Quality and Safety CAPAs.
· Performs GMP change control activities.
· Instructs staff on process/system integration and operation. Develops training plans.
· Supports new engineering projects. Creates project scopes, URS, and timelines
· Represents Manufacturing and Engineering Services on equipment projects managed by other engineering groups
· Reviews specifications, work instructions, protocols, drawings, and reports for technical accuracy
· Evaluates new equipment technologies. Participates in tech transfers
· Provides on-call support and works overtime as needed.
· Bachelor’s degree in Engineering (Chemical Engineering preferred) or Life Sciences
· Prior GMP experience in a biotech or sterile pharmaceutical manufacturing environment a plus. Prior experience with production scale biotech equipment a plus.
· Candidates without a BS in engineering require a minimum of 2-years of experience in GMP biotech manufacturing
The Fountain Group
About The Fountain Group:
Headquartered in Tampa, FL, with operations in all 5 regions, The Fountain Group is a Contingent Labor Resource Provider. The Fountain Group services clients directly, clients with an internal contingent labor program, and clients with an external managed service program.
At The Fountain Group, we know that searching for a new career can be stressful, which is why we take time to understand your skills and personal goals. We understand the importance of job flexibility and professional growth, and offer top-notch positions with leading employers. In fact, the majority of our clients are well known Fortune 100-500 companies. We also offer a variety of benefits to our associates to ensure their overall happiness.
In addition to assisting with your job search, we will help you through every step of the process offering online tutorials and additional resources to enhance your industry knowledge and skills. As your employment agent, we are dedicated to providing career counseling and job advice, knowing precisely what established companies want.
At The Fountain Group, we treat you like family, regardless of your proximity to our office. We are dedicated to providing you with an exciting, challenging and highly rewarding place to work. Become a part of our team today and let us put your talents to work.
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