Senior Engineer, Facility Operations (On-site

Job Description

The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical, and Early Development to rapidly develop processes for different biotherapeutics and efficiently produce material to supply clinical trials. We are also responsible for commercial process development, and development and implementation of new technologies.

We work with our partners in our Company Manufacturing Division to commercialize and launch new products.

• Act as an SME for the operation of innovative facility & utilities equipment, preparing/reviewing
  -user requirements.
• Support process & facilities equipment, and utilities (clean and grey) maintenance and calibration.
  
  - -
• Active member of Facility & Utilities Engineering team to ensure 24/7/ 365 building support for critical GMP operations.
• Support start-up activities including equipment qualification, training curricula, staff training, and CMMS implementation.
• Support operational readiness activities for launch of the new GMP facility.
• Manage vendor and contractors during maintenance and calibration of process equipment process.
  
  -
• Provide timely performance feedback and foster culture of trust for open dialogue.
• Coach Junior team members in the development planning process for soft and technical skills.
• Training skills:
  Ability to train technicians in technical, compliance, safety, and environmental procedures; ability to write SOPs and technical documents and present to peers and senior management.
• Drive cGMP and EHS compliance and promote a strong safety culture.

• Maintain a strong floor presence during GMP operations and support critical tasks as needed.
• Troubleshoot technical and equipment issues and make timely operational decisions.
• Initiate deviations, perform initial impact assessments, and support investigations.
• Author, revise, and approve SOPs, work instructions, and memos.
• Provide off-hours, weekend, holiday, and on-call support as needed.
• Oversee - Facility & Utilities
  -planning and associated activities.
• Collaborate across the network to share best practices and promote operational consistency.

• Bachelor's degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline with minimum of 5 years relevant experience, or a Master's degree with minimum 3 years of relevant experience.

• 3+ years of experience in a GMP-regulated clean utilities systems, biologics drug substance manufacturing equipment.
• Familiar with HVAC, cold rooms and temperature control units (TCU).

• Working knowledge of Computerized Maintenance Management System (CMMS)- & - Computerized Calibration Management System (CCMS).
• Strong understanding of GMP manufacturing environments, including upstream and downstream processing equipment.

• Working knowledge of cGMP, Quality Systems, and EHS requirements.
• Ability to train employees in technical, compliance, safety, and environmental procedures.
• Experience writing SOPs and technical documents.
• Working knowledge of Delta
  
  V.
• Strong troubleshooting, decision-making, and attention to detail skills.
• Demonstrated initiative and ability to work effectively in a fast-paced environment.
• Ability to use tools such as
  - Microsoft Office, and project management software.
• Ability to lift up to 25 lbs, if required.

• Experience with operationalization of GMP operations and/or large facility builds or renovations.
• Managing execution of capital projects.
• Experience with Veeva Quality Docs.
• Working knowledge of MES and SAP.
• Lean manufacturing and root cause analysis experience.
• Background in process engineering and providing support for a Biologics facility focused on upstream/downstream, or biologics/vaccine manufacturing operations
• Demonstrated ability to drive improvements and inspire others.
• Strong organizational, planning, communication, and presentation skills.
• Continuous improvement mindset and willingness to challenge the status quo.