Process Engineer

Samsung Biologics RKV; Rockville (MD); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

13 paid holidays

Vacation time

401K match

Medical, dental and vision coverage

Job summary

Samsung Biologics is seeking a Process Engineer at the Rockville site to provide technical engineering and project management for cGMP manufacturing, including capital projects, equipment optimization and tech transfer support. The role requires a BS in Engineering and hands-on coordination of design, testing, commissioning, and validation.

Experience with upstream/downstream equipment, CAPA, change control, and regulatory compliance is essential to drive process improvements and successful tech

Qualifications

• BS in Engineering or equivalent degree.
• Experience in biopharmaceutical manufacturing environments.
• Familiar with cGMP, change control and CAPA processes.

Responsibilities

• Provide engineering support for design, testing and optimization of biopharmaceutical manufacturing equipment up to 20,000L.
• Manage capital projects, retrofits and equipment acquisitions.
• Support technology transfer and scale-up activities.
• Lead resolution of technical issues with manufacturing operations.
• Collaborate with Validation, Automation, Quality, Metrology, Maintenance and Process Development.
• Apply process and utility system knowledge to improve efficiencies.
• Coordinate internal/external resources for timely, cost-effective projects.
• Act as SME and equipment owner for Upstream/Downstream equipment.
• Negotiate contracts, bids and change orders with vendors/contractors.
• Support CAPA investigations with key stakeholders.

Skills

Project management

Process engineering

Biopharmaceutical knowledge

Education

BS in Engineering

Job description

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

Samsung Biologics is a fully integrated CDMO offering state-of-the‑art contract development and manufacturing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award‑winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide.