Specialist, Operations

Job Description

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.

Position Description

As part of our company's Vaccine Manufacturing Organization, the Durham VMF team is seeking a highly motivated individual to serve as an Operations Specialist within the Operations Manufacturing Support team.  In this role, you must be able to work efficiently in a fast-paced environment and be hands-on when called for by the situation.  This role requires the ability to distill large quantities of complex data into simplified reporting and actionable measures, strong problem-solving skills, rapid disciplined decisions and prioritization of work. The position must also demonstrate strong collaboration and communication skills to enable interfacing with both internal contacts (site level) and external contacts (external customers, sister sites, vendors) to support these initiatives.

The position requires strong technical writing and problem-solving skills.  You will support critical project initiatives at the site and be involved in developing and implementing corrective actions.  Enthusiasm for continuously learning is a requirement.

Responsibilities include, but are not limited to:

• Supports the end-to-end product Value Stream Map driving production improvements, inventory management, cost reductions, and standard work at the shop floor level.

• Collaborates with Operations, Technology and Quality to author regulatory inspection observation responses and completes remediation projects, as required.

• Author and own execution of Operations protocols

• Assist in development of and own Operations corrective actions

• Author and revise Standard Operating Procedures

• Support of internal and external regulatory inspections, presenting on topics as needed.

• Day shift Operations representative for various site needs (Quality Assessments, Process Simulation support, etc.)

• Leads/Supports production and quality projects and process system improvements

• Participate in or lead problem-solving of real-time shop floor issues

• Support investigations of process deviation events, up to an including authoring and leading Quality Notification closure.

• Provide expertise to the production floor, understanding the full process requirements (safety, compliance, equipment, regulatory) in order to best understand and resolve production issues.

• Works independently and is capable of balancing shifting priorities without introducing disruption to the organization. Capable of working through uncertainty with minimal levels of manager direction.

• Potential to work on shift directly with an Operations team as needed for shop floor support.

Education Minimum Requirement

• Bachelor's degree in a Science or Production related field required.

• Bachelor of Science (B.S.) degree in Engineering (such as Chemical, Mechanical, Bio-Engineering, Bio-Medical Engineering, Industrial Engineering, etc.) or Science Fields (such as Chemistry, Biology, Microbiology, etc.) strongly preferred

Required Experience and Skills

• Minimum of 2 years of experience in a GMP regulated industry.

• Technical writing experience, i.e. investigations, change requests, standard operating procedures, batch records, protocols.

• Must be able to work both independently and within multi-functional teams in a fast-paced environment.

Preferred Experience and Skills

• Sterile manufacturing shop floor experience highly preferred.

• Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry.

• Experience with formal problem-solving techniques and a hands-on approach to problem-solving, such as root cause analysis and/or Lean Six Sigma tools.

• Experience using inventory management and maintenance planning software (MRP/ERP) such as SAP, automated control systems and electronic batch record systems.

• Experience man