Senior Specialist, Engineering

at  Merck Sharp Dohme

JOB DESCRIPTION

Position Description
Key vaccine product franchises are experiencing significant growth requiring staffing to support key initiatives. The Senior Specialist, Technical Services Process Engineering in the Bio Bacterial Manufacturing End-to-End is responsible for technical leadership and execution in the commercial manufacturing area while actively supporting, participating in, and embracing an empowered team culture. In this role, the Senior Specialist will work as an individual contributor as well as a team or project lead to lead work of others as required. Additionally, this role will contribute to the performance and results of a department, provide technical guidance, and anticipate and interpret client and/or customer needs to identify and implement solutions. Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments.

EDUCATION MINIMUM REQUIREMENT:

• Bachelor’s Degree in Engineering or Science

REQUIRED EXPERIENCE AND SKILLS:

• Minimum 5 years post-bachelor’s degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree plus 4 years; PhD degree plus 1 years).
• Experience in biologics, vaccine, or bulk sterile manufacturing facilities in a maintenance, process or validation support role
• Minimum of 3 yrs deviation management experience
• Root cause analysis certification

PREFERRED EXPERIENCE AND SKILLS:

• Advanced degree (M.S., Ph.D.) in science or engineering
• Ability to maintain strong working relationships with technical, quality and operations leaders
• Experience with equipment and automation troubleshooting.
• Experience in Process monitoring and trending tools
• DeltaV, GCM experience
• Regulatory inspection presentation experience with external regulatory authority representatives.
• Experience with one or more of the following areas: Fermentation | Purification

TRAVEL REQUIREMENTS:

10%

ADDITIONAL RESPONSIBILITIES INCLUDE:

• The candidate will continue to develop proactive-processes monitoring tools.
• Partner with cross-functional teams to evaluate data trends and develop projects to standardize and improve process performance with regard to yield and CQA performance.
• Design and conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale; Provide technical support to manufacturing for complex problems and issues
• Problem-solving skills and a hands-on approach to problem-solving, with a bias toward going to see problems for oneself in the field
• Support regulatory inspections based requests

EMPLOYEES WORKING IN ROLES THAT THE COMPANY DETERMINES REQUIRE ROUTINE COLLABORATION WITH EXTERNAL STAKEHOLDERS, SUCH AS CUSTOMER-FACING COMMERCIAL, OR RESEARCH-BASED ROLES, WILL BE EXPECTED TO COMPLY NOT ONLY WITH COMPANY POLICY BUT ALSO WITH POLICIES ESTABLISHED BY SUCH EXTERNAL STAKEHOLDERS (FOR EXAMPLE, A REQUIREMENT TO BE VACCINATED AGAINST COVID-19 IN ORDER TO ACCESS A FACILITY OR MEET WITH STAKEHOLDERS). PLEASE UNDERSTAND THAT, AS PERMITTED BY APPLICABLE LAW, IF YOU HAVE NOT BEEN VACCINATED AGAINST COVID-19 AND AN ESSENTIAL FUNCTION OF YOUR JOB IS TO CALL ON EXTERNAL STAKEHOLDERS WHO REQUIRE VACCINATION TO ENTER THEIR PREMISES OR ENGAGE IN FACE-TO-FACE MEETINGS, THEN YOUR EMPLOYMENT MAY POSE AN UNDUE BURDEN TO BUSINESS OPERATIONS, IN WHICH CASE YOU MAY NOT BE OFFERED EMPLOYMENT, OR YOUR EMPLOYMENT COULD BE TERMINATED. PLEASE ALSO NOTE THAT, WHERE PERMITTED BY APPLICABLE LAW, THE COMPANY RESERVES THE RIGHT TO REQUIRE COVID-19 VACCINATIONS FOR POSITIONS, SUCH AS IN GLOBAL EMPLOYEE HEALTH, WHERE THE COMPANY DETERMINES IN ITS DISCRETION THAT THE NATURE OF THE ROLE PRESENTS AN INCREASED RISK OF DISEASE TRANSMISSION.

Current Employees apply HERE
Current Contingent Workers apply HERE