Specialist, West Point Technical Operations

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 Senior Specialist, West Point Technical Operations is responsible for providing technical support to the lyophilized vaccine manufacturing areas within Technical Operations. Responsible for implementing continuous improvement projects as well as supporting equipment and investigations, as required. The responsibilities of a Senior Specialist, West Point Technical Operations may include, but are not limited to:

• 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., Collegeville, PAOn-Site Teamwork Operations Leadership Mentorship Mathematics Microsoft Excel Lifting Ability Microsoft Office Electrical Codes Vision Insurance Microsoft Outlook Technical Services Organizational Skills Technical Supervision Intellectual Curiosity Commercial Real Estate Artificial Intelligence +0 AVP, AI Product Management Lincoln Financial Radnor, PARemote Sales Gmail Backlogs Marketing Timelines Annuities Vertex AI Leadership Governance User Story Scalability Wholesaling Fundraising AWS Bedrock Data Science Azure OpenAI Data Privacy Data Analysis User Feedback Prioritization Tax Accounting Responsible AI Social Security Design Thinking Agentic Systems Computer Science Product Strategy Machine Learning Virtual Training Product Delivery Change Management Influencing Skills Product Management Business Valuation Thought Leadership Financial Services Product Leadership Workflow Management Retirement Planning AI Product Strategy User Experience (UX) Regulatory Compliance Stakeholder Engagement Artificial Intelligence Employment Applications Concept Drift Detection Engineering Design Process Balancing (Ledger/Billing) Verbal Communication Skills Project Portfolio Management Employee Assistance Programs Health And Wellness Coaching Financial Technology (FinTech) Key Performance Indicators (KPIs) Generative Artificial Intelligence MLOps (Machine Learning Operations) Artificial Intelligence Development Machine Learning Product Management Artificial Intelligence Infrastructure Master Of Business Administration (MBA) Financial Industry Regulatory Authorities Artificial Intelligence Product Management +0 Associate Director - Business Insights & Analytics, US Vaccines & ID (HIV) Merck & Co., Inc North Wales, PA*On-Site RStudio Curiosity Marketing Analytics Economics Leadership Innovation Statistics Compassion Agentic AI Mathematics Scalability Procurement Data Science Communication Biotechnology Public Health Accountability Prioritization Brand Strategy SAS (Software) Pharmaceuticals Medical Records Time Management Market Dynamics Self-Discipline Data Extraction Computer Science Machine Learning Telephone Skills Decision Science Learning Mindset Business Analysis Growth Mindedness Demand Management Data Storytelling Business Problems Project Management Influencing Skills Advanced Analytics Business Strategies Business Priorities Infectious Diseases Feature Engineering User Experience (UX) Contingent Workforce Healthcare Analytics Go-to-Market Strategy

Planning Teamwork Power BI Vaccines Timelines Mechanics Operations Leadership Automation Innovation Compassion Adaptability Communication Presentations Investigation Risk Analysis Change Control Process Design Pipeline Pilot Lyophilization Self-Motivation Telephone Skills Technical Support Impact Assessment Biopharmaceuticals Project Management Influencing Skills Strategic Planning Technical Services Strategic Thinking Process Validation Root Cause Analysis Process Development Contingent Workforce Process Optimization Chemical Engineering Production Equipment Demonstration Skills Technical Consulting Deviation Management Regulatory Compliance Continuous Monitoring Analytic Applications Mechanical Engineering Biomedical Engineering Change Control Process Manufacturing Processes Technical Documentation Manufacturing Operations Deviation Investigations Good Manufacturing Practices Pharmaceutical Manufacturing Continuous Improvement Process Spotfire (Data Analytics Software) Manufacturing Execution System (MES) Product And Manufacturing Information, 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., * 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.)

Preferred Experience and Skills:

• 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.

Required Skills: Adaptability, Biomedical Engineering, Change Control Processes, Continuous Monitoring, Customer-Oriented, Deviation Management, Engineering Standards, Good Manufacturing Practices (GMP), Improvement Projects, Maintenance Engineering, Manufacturing Execution Systems (MES), Manufacturing Process Validation, Manufacturing Support, Pharmaceutical Manufacturing, Process Optimization, Quality Risk Assessment, Regulatory Compliance, Regulatory Submissions, Root Cause Analysis (RCA), Strategic Planning, Strategic Thinking, Teamwork, Technical Consulting, Technical Support, Technical Transfer, Innovation Leadership Stakeholder Management Dealing With Ambiguity Intellectual Curiosity Artificial Intelligence Relationship Management Requirements Management Electronic Medical Record SQL (Programming Language) Data-Driven Decision Making Product Lifecycle Management Secondary Source Information Python (Programming Language) Customer Relationship Management Natural Language Processing (NLP) Master Of Business Administration (MBA) +0

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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The salary range for this role is $117,000.00 - $184,200.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.