Associate Director, Engineering

Merck Merck · Pharma · NC

Associate Director, Engineering role at Merck focused on providing technical support to vaccine manufacturing operations within a cGMP environment. Responsibilities include leading a team, coordinating responses to process upsets, prioritizing projects, and supporting regulatory audits. Requires a strong background in biological and/or vaccines industries with experience in manufacturing and problem-solving.

What you'd actually do

  1. Provide leadership and direction for a team of highly technical individual contributors and be responsible for all human resource activities including one-on-one meetings, team development, hiring, talent assessment and performance reviews.
  2. Coordinate responses to process upsets, including short-term mitigation to return to service and assessment of product impact
  3. Prioritize projects, timelines, and resource allocation to improve safety, compliance, stability, cost and capacity
  4. Approve investigations, SOPs, change requests, protocols, CAPAs, Quality Risk Assessments
  5. Support of regulatory audits with coaching Subject Matter Experts (SMEs) and presenting to auditors

Skills

Required

  • B.S. Degree in Chemical/Bio-Chemical Engineering or Biological/Chemistry Sciences or related disciplines with 8 years in biological and/or vaccines industries; OR M.S. Degree in Chemical/Bio-Chemical Engineering or Biological/Chemistry Sciences or related disciplines with 6 years in biological and/or vaccines industries; OR PhD Degree in Chemical/Bio-Chemical Engineering or Biological/Chemistry Sciences or related disciplines with 3 years in biological and/or vaccines industries
  • Recognized technical expert with experience in vaccine or biologics manufacturing within a cGMP environment
  • Demonstrated ability to develop innovative solutions for complex problems and business processes or systems
  • Demonstrated experience in solving major investigations within cGMP manufacturing
  • Demonstrated effective written and verbal communication skills with ability to influence peers
  • Ability to build strong collaborative relationships with internal partners and sites as well as with external partners
  • Biologics
  • Commercialization
  • Drug Product Manufacturing
  • GMP Compliance
  • People Leadership
  • Project Management
  • Regulatory Requirements
  • Technical Guidance
  • Technology Transfer
  • Vaccine Manufacturing

Nice to have

  • People management and/or mentoring experience
  • Demonstrated experience in sterile vaccines or biologics drug product commercial manufacturing unit operations such as: bulk formulation, vial filling, lyophilization, sealing, and container inspection
  • Familiarity with risk management and/or our Company's Production Systems (MPS) methodologies
  • Experience with deviation management, change control, project management, and/or process validation
  • Strong capability in applying scientific and engineering principles for problem solving and implementation of solutions
  • Expertise in exploring complex manufacturing data to identify opportunities for improvement
  • Working knowledge of regulatory requirements in accordance with GMP manufacturing operations

What the JD emphasized

  • cGMP environment
  • major investigations within cGMP manufacturing