Manufacturing Engineer- Biotechnology

Full-time - Entry Level

Baltimore, MD

10,001+ employees

About the position

Responsible for manufacturing engineering activities related to all biological products, corrective and preventative actions related to manufacturing non-conformances / issues, documentation, cost reduction, interface with engineering, development, quality, product management, and service, and training of manufacturing personnel. Supports LEAN culture focusing on standardization, quality, improved performance and increased throughput.

Responsibilities

• Managing high-throughput, large scale cell culture expansions
• Develop, maintain and improve processes and test protocols for biosensor and finished goods manufacturing which comply with cGMP practices.
• Create and maintain manufacturing job test procedures, work instructions, and master process documents.
• Maintain master material data in SAP for all biological products, including component product data, bills of materials and production routings.
• Determine reagent and inventory needs to maintain cell culture operations
• Primary liaison with Development and Engineering teams on new products and engineering issues.
• Perform validation testing on new and updated products and processes and implementing these changes in production
• Develop, improve, and implement cGMP practices in biotechnology lab settings
• Perform root cause analysis (RCCA) for issues related to biological products and implement effective corrective and preventive actions.
• Complies with and ensures department compliance with all Company policies and procedures.

Requirements

• BS Biological Engineering, equivalent experience in lieu of degree considered
• 2-5 years of related experience in a discreet manufacturing environment, ideally with extensive hands-on experience in cell culture including working with adherent and non-adherent mammalian cell lines, preparing master and working banks, and with cryopreservation techniques.
• A working knowledge of non-adherent mammalian cell culture and expressing proteins in mammalian cell lines is a plus.
• Advanced computer skills including Excel, Microsoft Word and Outlook; SAP or equivalent is preferred; CAD-based systems and bioinformatics is a plus.
• Hands-on experience with ISO 9001 and Lean Manufacturing.
• Hands on knowledge in additional ISO quality systems and cGMP manufacturing is a plus.
• Working knowledge of cell biology, molecular biology and immunology.
• Working knowledge of basic microbiology techniques and ability to work with BSL-2 level pathogens.
• Ability to design experiments, interpret data, and prepare final reports.
• Ability to troubleshoot protocols and procedures.
• Team player and possesses a strong capability to work independently.
• Strong verbal and written communication skills.
• Ability to gain the trust and respect of your team members.
• Good organizational skills and attention to detail.

Benefits

• Comprehensive benefits including healthcare
• 401K savings plan
• Company holidays
• Vacation
• Sick time
• Parental leave
• Employee assistance program