Job Description
West Point, PA Technical Operations for the Incoming Materials (IM) team is seeking a highly motivated individual for a Specialist, Engineering position. The successful candidate will partner with Suppliers, IM Quality, Planning, Procurement, Validation, Warehouse, Supplies Inspection, Global IM Tech Ops, Supplier Development & Performance Development, and Supplier Quality Management to ensure that the incoming materials used across the West Point site support the manufacture of the highest quality vaccines.
Responsibilities
Execute change management for supplier-initiated changes and site-initiated incoming material projects.
Author and update GMP technical documents and SOPs to support incoming material qualification and change control.
Design and conduct experimental protocols to support incoming material qualification, testing, and improvement projects.
Provide technical support for Warehouse, Supplies Inspection, and incoming materials used in manufacturing areas across the West Point site.
Lead or support execution of Quality Risk Assessments.
Support regulatory inspection activities for the facility.
Support IM Deviation Management team investigations and Corrective/Preventative Actions (CAPAs) if necessary. Improve Right-First-Time performance and prevent/reduce deviations.
Support and/or execute continuous improvement projects to increase compliance, simplify/standardize processes, resolve release issues, and gain efficiencies.
Manage project timelines to ensure key compliance and customer due dates are met; escalate potential delays, and develop remediation plans when possible.
Support team safety, environmental, and compliance objectives.
Qualifications
Required
Bachelor’s Degree or higher (Engineering or Sciences, preferred)
Minimum two (2) years post-bachelor’s degree experience in GMP manufacturing/laboratories and/or technical support of GMP manufacturing operations/laboratories.
Experience in change control and/or project support role.
Highly developed communication, leadership, and teamwork skills.
Ability to manage projects/work to schedule/deadlines.
Preferred
Experience in biologics, vaccine, or bulk sterile manufacturing facilities.
Change Control author
Supplier Change Notification experience
Project Management
Technical Writing
Required Skills:
Adaptability, Biopharmaceutical Industry, Biopharmaceutical Operations, Biopharmaceutics, Change Controls, Change Management, Continuous Improvement Projects, Data Analysis, Engineering Principle, Engineering Standards, Estimation and Planning, Experimentation, GMP Compliance, Improvement Projects, Process Optimization, Professional Engineering, Project Management, Quality Risk Assessment, Software Proficiency, Supplier Quality Management, Teamwork, Technical Communication, Technical Problem-Solving
Preferred Skills:
Current Employees apply
Current Contingent Workers apply
US and Puerto Rico Residents Only:
The salary range for this role is
$87,300.00 - $137,400.00
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 .
You can apply for this role through (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:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
08/1/2026
*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
