The Process Engineer’s function at the Rockville Biopharmaceutical site is to provide technical engineering and project management services for cGMP manufacturing operations including capital project management, equipment optimization and tech transfer support. Motivated engineering professional who can manage small to medium projects while supporting manufacturing operations.
KEY RESPONSIBILITIES:
- Provide engineering support for the design, testing and optimization of biopharmaceutical manufacturing equipment up to 20,000L scale including stainless and single-use bioreactors, centrifuges, chromatography systems, filtration skids, pasteurizers, chromatography skids, etc.
- Manage capital projects and engineer solutions involving retrofits, modifications and acquisition of process equipment.
- Support execution of technology transfer and scale-up activities.
- Lead resolution of technical issues with manufacturing operations and equipment.
- Collaborates with other manufacturing support groups including Validation, Automation, Quality, Metrology, Maintenance and Process Development.
- Applies knowledge of process and utility systems to make recommendations to improve manufacturing systems, equipment and process efficiencies.
- Experience with project management (schedule, cost, communications) and coordination of internal and external resources to execute projects in a timely and cost-effective manner.
- Subject matter expert (SME) and equipment owner for Upstream and/or Downstream process equipment with ability to assist in the execution of design, procurement, testing (FAT, SAT, commissioning), installation and validation activities.
- Capable of negotiating contracts, bids, and change orders with vendors or contractors.
- Support investigations and recommend solutions with key stakeholders in order to gain a consensus on effective corrective and preventive actions (CAPA)
Experience:
- Experience supporting biopharmaceutical, biotechnology, pharmaceutical, or other regulated manufacturing environments.
- Knowledge of upstream and/or downstream process equipment and associated utility systems.
- Experience managing capital projects and supporting equipment qualification, commissioning, and validation activities.
- Familiarity with cGMP regulations, change control, deviation investigations, root cause analysis, and CAPA processes.
Education
- BS in Engineering or equivalent degree
The anticipated salary range for this position in Maryland is $89,925 to $119,900 plus annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.
Benefits:
· 13 paid holidays · Vacation time · 401K match · Medical, dental and vision benefit effective day one of employment