Associate Specialist, Engineering Deviation Management (Hybrid)

at  Merck Sharp Dohme

JOB DESCRIPTION

The function of this position is to provide engineering technical support to the manufacture of liquid vaccines. The role encompasses technical services support primarily in the area of deviation management. Scope will cover bulk vaccine manufacturing and may span across multiple areas of focus.

EDUCATION MINIMUM REQUIREMENT:

• B.S. in Mechanical or Chemical Engineering Degree or other Engineering/Science Degree

REQUIRED EXPERIENCE AND SKILLS:

• Engineering, mechanical or science educational background
• Minimum of 1-year post-Bachelor’s degree experience in support of Production, Process Engineering, Validation, Technical Services or related experience
• Demonstrated ability to work both independently and as a part of a team.
• Demonstrated leadership and teamwork skills, excellent analytical abilities, established written and verbal communication skills

PREFERRED EXPERIENCE AND SKILLS:

• Hands-on technical services experience in drug substance vaccine manufacturing
• Experience with troubleshooting biotech equipment and closed system processing.
• Experience with SAP, PI, DeltaV, ProCal
• Ability to read Piping and Instrumentation Diagrams
• LSS/MPS certification/experience.

TRAVEL REQUIREMENTS:

No Travel Required

POSITION RESPONSIBILITIES:

• The role will include authoring process deviations, performing human performance consultations, generation and authoring of CAPAs, implementation of CAPAs (where applicable), deviation trending and reporting. Participate in real time investigations with the goal of fully understanding root cause and product impact.
• Collaborate with Operations, Automation, EM&U and Quality to restart a drug substance manufacturing facility from a shutdown state. This includes proactive identification of best practices and implementation of HuP improvements.
• Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.
• Complete projects to improve the performance of our processes, including projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times
• Manage project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible
• Support requests for regulatory inspections related to process overviews, investigations, projects and validation.
• Support team safety, environmental, and compliance objectives.
• Collaborate effectively with the area Managers, Operators/Technicians, support groups (Mechanical Services, Trades, Automation, Technology), Quality, and Planning.
• Actively use and champion the use of Lean Six Sigma (LSS) and Production System (MPS) tools, both in problem solving and day-to-day operational activities.
• Author updates to Master Batch Records (production process descriptions) and SOPs (Standard Operating Procedures).

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