Process Engineer

Provide technical engineering and project management services for cGMP manufacturing operations including capital project management, equipment optimization, and tech transfer support.

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, and chromatography skids.
• 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.
• Collaborate with other manufacturing support groups including Validation, Automation, Quality, Metrology, Maintenance, and Process Development.
• Apply 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.
• Serve as 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.
• Negotiate contracts, bids, and change orders with vendors or contractors.
• Support investigations and recommend solutions with key stakeholders to gain consensus on effective corrective and preventive actions (CAPA).

Requirements

• 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.
• BS in Engineering or equivalent degree.

Pay

The anticipated salary range for this position in Maryland is $89,925 to $119,900 plus annual bonus, when eligible. The final salary offered may vary based on factors such as experience, skills, education, and business needs.

Benefits

• 13 paid holidays
• Vacation time
• 401K match
• Medical, dental, and vision benefits effective day one of employment