Senior MDCP Method Validation & DV Lead

Merck; West Point (PA); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical benefits

401(k)

Job summary

Merck’s Center for Packaging & Device Analytics (CPDA) in West Point, PA seeks an Associate Principal Scientist/Engineer to manage design verification testing and method validation across internal and external labs. You will lead DV activities for commercial MDCP products and ensure cGMP, ISO 13485, and GDP compliance.

You will mentor CPDA analysts, collaborate with program leads to advance analytical technologies, and contribute to safe, compliant testing and documentation in a fast-paced

Qualifications

• A minimum of 3 years with PhD, or 6 years with BS or MS, in an industry role centered on analytical testing.
• Successful work within a cGMP or ISO 13485 certified analytical laboratory.
• Strong knowledge and experience with regulatory compliance principles GMPs, GDPs and quality assurance practices related to analytical testing

Responsibilities

• Strategic and tactical (day-to-day) management of design verification testing to support commercial products and meet project timelines.
• Technical oversight of method development, validation, and implementation at internal and external laboratories.
• Ensuring safety, environmental and cGMP & ISO 13485 compliance for all lab activities and operations.
• Drive test method development and implementation of new instrumentation/analytical technologies for the lab.
• Oversight and technical coaching of CPDA analysts in the ISO laboratory.

Skills

Analytical Development

Analytical Testing

GMP Laboratory

GMP Testing

Interdisciplinary Collaboration

Mechanical Testing

Medical Device Management

Medical Devices

Medical Device Technologies

Medical Device Testing

Synthetic Chemistry

Test Procedure Development

Education

BS, MS or PhD in Mechanical, Chemical or Biomedical Engineering or associated scientific discipline, such as Chemistry

Job description

Merck’s Center for Packaging & Device Analytics (CPDA) in West Point, PA seeks an Associate Principal Scientist/Engineer to manage design verification testing and method validation across internal and external labs. You will lead DV activities for commercial MDCP products and ensure cGMP, ISO 13485, and GDP compliance.

You will mentor CPDA analysts, collaborate with program leads to advance analytical technologies, and contribute to safe, compliant testing and documentation in a fast-paced