Job Description
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.
Position Description
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.
Position Qualifications:
Education Minimum Requirement:
- B.S. Degree or higher in Engineering or other equivalent technical fields.
Required Experience and Skills:
- 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
**Preferred Skills: **
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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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
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully ** 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.
**Employee Status: **
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
06/15/2026
***A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. **