Senior Specialist, Engineering

Merck • Upper Gwynedd Township, PA

1d • $117,000 - $184,200 • Hybrid

About The Position

Our Engineers support internal and external manufacturing operations to remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. The West Point Lyophilization Technical Operations organization is seeking a highly motivated individual for a Senior Specialist, Engineering position. The successful candidate will have the opportunity to contribute to the performance and results of the Live Virus Vaccines (LVV) drug product manufacturing at our company's West Point Processing Facility by providing technical guidance and anticipating and interpreting customer needs to identify and implement solutions to support.

Requirements

• B.S. Degree or higher in Engineering or other equivalent technical fields.
• Minimum 6 years post-bachelor’s degree experience in Good Manufacturing Practices (GMP) functional area or support of a Good Manufacturing Practices (GMP) functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance (or M.S. degree plus 4 years; PhD degree plus 2 years).
• Experience in deviation management and/or change control and/or equipment support and/or project support role.
• Experience in vaccine or biologics manufacturing within a cGMP environment
• Experience authoring technical documentation within a cGMP context.
• Proven leader with influence and highly developed communication, leadership and teamwork skills.
• Experience with project strategic plan development and ability to manage projects to schedule / deadlines.
• Experience with Data Analytic Tools (Spotfire, Pipeline Pilot, MANTIS, Power BI, JMP etc.)

Nice To Haves

• Change Control author
• Experience with lyophilization of biologics or vaccines within cGMP sterile manufacturing facilities.
• Experience with remediation of product performance (potency) related issues.
• Authored complex process change control.
• Experience with Manufacturing Execution Systems (MES)
• Experience with responding to regulatory questions and/or face-to-face presentations of technically complex subjects to multiple agencies.
• Experience with Quality Risk Assessment (QRA)
• Chemical Engineering, Mechanical Engineering, Biomedical Engineering or Biological Sciences degree.

Responsibilities

• Providing technical support to the Lyophilization manufacturing area.
• Responsible for implementing continuous improvement projects.
• Work as an individual contributor, team or project lead.
• Author or approve Change Control documentation for complex process, validation, analytical, equipment, facility/utility and/or automation changes.
• Managing on-time implementation and close-out to meet project, production and supply timelines.
• Escalates any potential delays and develop remediation plans when possible.
• Apply advanced technical skills to align activities with department, site and franchise objectives.
• Supports, executes, and/or leads continuous improvement projects that increase compliance, simplify/ standardize and/or gain efficiencies.
• Examines complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
• Provides advanced technical support to manufacturing for complex problems and issues including process/equipment.
• Design, conduct and/or reviews and approve experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
• Monitor the health of the process through continuous monitoring and the annual process review or continuing validation activities. This includes Continued Process Monitoring (CPV).
• Author and update technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
• Prepare documentation to support regulatory submission and participates in regulatory inspection activities for the facility.
• Provides on-the-floor support of complex operational and technical (process/equipment) issues.
• Performs and/or reviews and approves deviation investigations aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment.
• Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.
• Completes and/or leads projects to improve the performance of our processes, including investigation Corrective/Preventative Actions (CAPAs), projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield/efficiency, reduce cost, or lower our processing cycle times.
• Supports team safety, environmental, and compliance objectives.
• Collaborates effectively with the area Coaches, Operators/Mechanics, support groups, Quality, Planning, project teams, and external component and equipment vendors.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Senior