Bio Process Operations Technician

Merck & Co.•Wilson, NC

79d•Onsite

About The Position

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products. The BioProcess Technician is responsible for providing shop floor operations and environmental monitoring support to the aseptic manufacturing areas of the manufacturing facility at the Wilson, NC Site. Responsibilities will include direct operational support for manufacturing activities including formulation, CIP/SIP, packaging, inspection and aseptic primary filling. This position will also be responsible for performing various supporting roles within the facility such as executing routine room and equipment disinfection and managing the movement of gowning, disinfectants, and materials to support the manufacturing areas. In addition to supporting operations activities, the role will be responsible for ensuring that EHS and GMP compliance is maintained within their area of assignment. This position will be an individual contributor and member of the Operations team within the integrated process team (IPT).

Requirements

High School diploma or equivalent and previous experience operating, maintaining, troubleshooting, and/or repairing industrial equipment is preferred | Associates degree in Business, Science, or Technology-based field and/or bio-pharma focused certificates such as Bioworks preferred
Three or more years in a GMP manufacturing facility (aseptic GMP environment strongly preferred)
Ability to work independently as Team member
Interpersonal skills with ability to influence and support others through a culture of inclusion, feedback, and empowerment
Leadership ability, peer training experience, and/or productivity improvement activities strongly preferred.
Ability to gown and work in an aseptic environment
Ability to work with computerized and automated systems
Willing to work irregular hours to support multi-shift operation on an as needed basis
Accountability
Accountability
Analytical Problem Solving
Biological Manufacturing
Biopharmaceuticals
Biopharmaceutics
Cleanroom Gowning
Computer Literacy
Data Integrity
Documentations
Environmental Monitoring
Global Manufacturing
GMP Compliance
GMP Operations
Good Manufacturing Practices (GMP)
Healthcare Innovation
Laboratory Processes
Lean Manufacturing
Machinery Operation
Manufacturing
Manufacturing Quality Control
Packaging Operations
Pharmaceutical Manufacturing
Production Operations
Production Scheduling

Nice To Haves

Aseptic filling, visual inspection systems, CIP/SIP systems, packaging equipment and similar aseptic formulation and filling operations
Working in a regulated environment (FDA, etc.) and basic knowledge of cGMPs as they apply to the vaccine/pharmaceutical industry
Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies
SAP/MES/electronic log book basic knowledge from a production execution perspective
Ability and drive to work autonomously and help organize priorities and work with other team members
Outstanding communication skills both within direct team and across multiple shifts to ensure success of overall team
Ability to support technical writing of documents such as standard operating procedures (SOPs)

Responsibilities

Execute manufacturing operations, environmental monitoring, and facility disinfection within the Pod vaccine manufacturing facility
Set up and operate vaccines formulation, CIP/SIP, aseptic primary filling, packaging, inspection and additional support equipment within qualified parameters
Identify potential equipment problems and partner with other Vaccines Maintenance Technicians to ensure appropriate resolution
Demonstrate ability to troubleshoot process, electronic systems and equipment for routine and basic problems
Perform other duties as requested by the Operations coach
Responsible for performing work in a safe manner, following identified safety procedures (hazardous work permitting, LOTO, HECPs), and using applicable safety equipment / personnel protective equipment (PPE)
Execute operations functions in accordance with current Good Manufacturing Practices (cGMPs) and standard operating procedures (SOPs)
Complete documentation in batch records, electronic logs, or other systems in accordance with site procedure
Maintain good housekeeping and 5S in assigned work area
Adhere to the highest level of data integrity while performing duties
Identify potential quality or safety issues. Escalate as per IPT management processes and assist in the investigation, root cause determination, and CAPA implementation
Ensure that startup activities for area of assignment are executed such that project deliverables and timelines are met
Closely monitor team / process performance and improve reliability through problem solving and continuous improvement
Set up and operate equipment in alignment with established training and procedures to ensure reliable operation with minimal delays or discards
Identify and help implement continuous improvement and productivity enhancements within the IPT Team
Partner with Technicians and cross-functional support groups for assigned area to maintain an inclusive and positive work environment
Demonstrate a high degree of maturity and personal integrity. Strictly adhere to all site policies on personal conduct and attendance
Train, develop, and mentor other team members to share experience and best practices
Pursue knowledge and skills in assigned area from an operations perspective and share that information readily with team
Maintain a culture of continuous improvement / MPS focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving
Routinely demonstrates leadership and conflict-resolution ability. Demonstrates a willingness to provide and receive constructive feedback in 360° performance review