Position Summary Manage and lead Engineering projects at the Durham site. Ensure required Engineering support and oversight for the manufacture and packaging of the BACT/ALERT product line are available to meet or exceed production targets and quality. Provide Commissioning, Qualification and Validation (CQV) and project management oversight to ensure assets are efficiently deployed to minimize scrap and rework while maximizing OEE, cost of finished goods, and yield. Provide direct leadership for business-critical projects including, design, startup and implementation of new equipment, facilities, and processes. Primary Duties
Manage selection and review vendors for BACT/ALERT Production
If possible, ensure multiple vendors are approved.
Ensure product specifications are up to date and can be reasonably adhered to.
Participate in vendor performance reviews.
Research and evaluate new vendors as required.
Evaluate cost reduction opportunities along with Purchasing for vendors.
Create Clear and Concise Capital and Expense Reports
Provide supporting facts and documentation to support project deliverables.
Provide the information in a timely manner.
Monitor progress of the projects to ensure they move at the planned pace.
Subject Matter Expert for Commissioning, Qualification and Validation (CQV) Activities
Develop and maintain Validation Plans.
Develop and maintain system lifecycle documentation.
Develop and execute CQV testing protocols.
Maintain validation content oversight, provide guidance, and create draft validation master templates.
Provide support to Quality Validation Department for equipment and process periodic reviews.
Provide support in FDA, ISO, customer and other inspections and audits.
Lead and Participate in Change Management for Engineering Department
Actively participate in sites Change Review Board (CRB) for the Engineering Department.
Manage and/or Lead change controls related to scope of work.
Provide supporting facts and documentation to support project deliverables.
Monitor progress of the projects to ensure they move at the planned pace.
Execute Assigned Projects or Scope of Work
Manage project schedules as assigned.
Work in a team environment to complete projects.
Coordinate or provide training during implementation of assigned projects.
Monitor Equipment Performance
Review OEE results, analyze data, and implement improvements as required.
Support MFG equipment and processes as required.
Review in-process scrap and act to improve as required.
Education and Skills
Bachelor’s Degree with a minimum 2 years of experience within a manufacturing environment with direct experience in Commissioning, Qualification and Validation.
Minimum 3 years working in a cGMP environment required (ISO/FDA regulated preferred)
Demonstrated ability to exercise leadership, diplomacy, and problem-solving skills when coordinating and working within all levels of the organization.
Basic Computer Skills required; must be experienced and proficient in the use of:
Microsoft Office tools (specifically Word & Excel).
Advanced use of MS Word preferred.
Excellent documentation and communication skills (written & verbal).
Position requires strong attention to detail and GMP experience (including knowledge of change control, validation, and commissioning processes).
Ability to work successfully autonomously, as an active contributor on a team.
Experienced with equipment change control and standard operation procedures (generation/revision).