Senior Process Engineer
Emergent Biosolutions
Baltimore, Maryland
senior
engineer
emergent
process equipment
senior
design
management
technical
engineer
operational
engineering
manufacturing
safety
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February 12, 2023
Emergent Biosolutions
Baltimore, Maryland
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
- Demonstrates technical problem-solving skills related to complex project execution and site equipment / systems troubleshooting challenges for process equipment relevant to drug substance manufacturing.
- Must have hands on working knowledge of some or all of the following:
- Single Use systems (Bioreactors, Mixers, Chromatography, Tangential flow filtration (TFF), harvest/clarification)
- Stainless steel systems (buffer/media preparation, Clean-in-place (CIP), Steam in place (SIP)
- Participate as a team member in high performing cross-functional teams and timely execution of work assignments
- Must possess tactical capabilities in organizing required tasks in executing complex project work
- Must exhibit customer focus and effectively communicate with peer-level partners, user groups, senior management and clients.
- In depth working knowledge of cGMP requirements for biopharmaceutical manufacturing of Bulk Drug Substances.
- Must be compliant with processes, procedures, and instructions for all activities on assigned tasks.
- Participate in process equipment design, build, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT) activities including the following.
- Develop Capital planning and Execution (CAPEX) for planned and unplanned process equipment needs
- Coordinating efforts with end users, clients and equipment fabricators
- Collaborate, review and comment on equipment documentation (Design documents, Site procedures (SOP s), and validation protocols.
- Assisting with equipment integration to site network, other systems and site historian
- Planning site activities with vendors.
- Support the validation group during execution of Installation and Operational Qualification (IQ/OQ) activities.
- Assistance to including onsite support on off hours, nights, weekends, and holidays as needed to support the manufacturing production activities.
- Supporting efforts for process equipment located within a cleanroom environment.
- Participate in daily huddle meetings as a representative for process equipment.
- Support site process improvement initiatives.
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