Job description

Senior Manufacturing Engineer

Biotechnology Research

Rockville, MD

Start Date: ASAP

I am working with a fast-growing Biotechnology Research company based in Maryland which aims to transform patient lives with the curative potential of gene therapy. They are looking to hire a Manufacturing Engineer to join their team to provide engineering support to all manufacturing operations.

This position will be responsible for the design and continuous improvement of existing equipment and processes and take part in the selection and implementation of new process equipment.

Key Responsibilities:

• Lead the design, implementation, and commissioning for new process equipment and modifications to existing equipment of moderate to complex scope
• Author and review technical protocols, testing documents, operating procedures, change control documents and qualification protocols associated with manufacturing equipment and processes
• Review design specifications, P&ID drawings, functional specifications, and automation control strategies
• Develop user requirements, system risk assessments and request for proposal packages for equipment procurement
• Ensure successful manufacturing production runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment and process issues, bring unresolved issues to supervisor and/or other team members
• Participate in cross-functional teams to improve existing processes and drive change to increase efficiencies or minimize waste
• Perform investigations of minor manufacturing deviations and anomalies related to failure of manufacturing equipment and/or facility systems

Essential Experience:

• Bachelor’s Degree in Chemical, Electrical or Computer Engineering, Life Science or similar, Master’s degree preferred
• 8+ years’ relevant experience in manufacturing setting, preferably in Biotech or Pharmaceutical industries
• Demonstrated knowledge of cGMP manufacturing and regulatory requirements
• Demonstrates a good understanding of equipment, instrumentation, and materials of construction to design, specify, procure, start-up, fully commission and troubleshoot equipment and systems
• 2+ years’ experience in senior/managerial positions
• Knowledge of industry standards and guidelines, such as, ASME BPE, ISPE Baseline Guides and CFR’s

Job Type: Full-time

Salary: $100,000.00 - $130,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Experience level:

• 8 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person
• Manufacturing facility

Ability to commute/relocate:

• Rockville, MD 20850: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• Manufacturing Engineer: 8 years (Preferred)
• Biotechnology or Pharmaceutical: 6 years (Preferred)
• Leadership: 2 years (Preferred)
• Continuous improvement: 8 years (Preferred)

Work Location: In person

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