Senior Specialist, Engineering

Merck Merck · Pharma · DE

Merck is seeking a Senior Specialist in Global Engineering Solutions to support Technology Center, Large Molecule Process Engineering. This role involves planning, design, and implementation of capital projects, process & facility design, equipment selection, vendor management, factory acceptance testing, facility start-up, commissioning, construction support, equipment qualification, and technology transfer. The position requires a Bachelor's degree in a relevant engineering field and a minimum of four years of experience in GMP manufacturing or technical support, with at least two years in project leadership. Experience with capital management, downstream process engineering, bioconjugation, and potent compound manufacturing is preferred. The role is project-based and requires on-site support, with flexibility for travel.

What you'd actually do

  1. Planning, design, and implementation of capital projects including scope generation
  2. Process & facility design
  3. Capacity Assessments
  4. Equipment selection
  5. Vendor management and interaction
  6. Factory acceptance testing
  7. Facility start-up and Commissioning
  8. Construction support and/or management
  9. Equipment qualification
  10. Technology transfer
  11. Process demonstration

Skills

Required

  • Bachelors Degree or higher in Mechanical, Chemical, BioChem, BioMech, or Computer/Electric Engineering or Applicable Science
  • Minimum of four years post-bachelor’s degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations
  • Minimum of two years project leadership and/or management
  • Written and verbal communication, leadership and teamwork skills.
  • Experience with engineering design, equipment start-up and operation, vendor interface, risk assessment and process safety
  • Ability to travel, both domestic and international
  • Antibody Drug Conjugates (ADC)
  • Bioconjugation
  • Capital Projects
  • Change Control Processes
  • Customer-Oriented
  • Deviation Management
  • Engineering Design
  • Engineering Standards
  • GMP Compliance
  • Good Manufacturing Practices (GMP)
  • Maintenance Engineering
  • Manufacturing Process Validation
  • Oral Communications
  • Process Optimization
  • Process Safety
  • Project Leadership
  • Project Management
  • Regulatory Compliance
  • Root Cause Analysis (RCA)
  • Strategic Thinking
  • Teamwork
  • Technical Support
  • Technical Transfer

Nice to have

  • Downstream Process Engineering and Bioconjugation.
  • Estimating and/or Project Controls experience or expertise
  • Capital Management Process Experience
  • Experience with equipment life cycle approach including specification, selection, testing & commissioning, troubleshooting and qualification
  • Construction Management Experience
  • Experience with OEB5 potent compound manufacturing, Antibody Drug Conjugates (ADCs), process safety, and industrial hygiene.

What the JD emphasized

  • Minimum of four years post-bachelor’s degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations
  • Minimum of two years project leadership and/or management
  • Experience with engineering design, equipment start-up and operation, vendor interface, risk assessment and process safety