Senior Engineer, Facility Operations (On-site)

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.

This role will support the Next Generation Biologics (NGB) facility, a premier, state-of-the-art facility that is a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway, NJ. This facility will be fully online in the next few years, both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It can meet all historic, currently existing, and cutting-edge biologics program demands from supporting development to pilot scale, small and large scale potent material handling, and the ability to integrate new technologies and cell-line platforms.

Responsibilities

• 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.
• 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.

Requirements

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.

Skills

• 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 DeltaV.
• 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.

Preferred Experience And Skills

• 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.

Pay

The salary range for this role is $117,000.00 - $184,200.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Schedule

• Shift: 1st - Day
• Travel Requirements: 25%
• Provide off-hours, weekend, holiday, and on-call support as needed.