2024 Associate Specialist

Job Description

The West Point, PA campus is our company's largest vaccine manufacturing facility with more than 2000 employees. This facility manufactures bulk and/or final dosage forms for all our vaccine products and is growing to meet the vaccine demands of the future.

The Building 63A Syringe Filling Facility Project team is seeking a highly motivated individual to fill an open position to support the start-up of a new vaccine filling & inspection facility at the West Point site. This is a great opportunity for individual to be part of a $367MM project and learn how to do facility start-up that will include design, commissioning, equipment qualification and vaccine drug product process demonstration and support of facility licensure.

The Specialist, Technical Operations is responsible for technical support for vaccine manufacturing unit operations while actively supporting, participating in, and embracing an empowered team culture. In this role, the Asso. Specialist will work as an individual contributor as well as a team within a cross-functional group that includes Global Engineering Services, Global Technical Operations, West Point Operations, Quality, Automation, and others.

Additional responsibilities include:

• Support successful demonstration of unit operations for the technology transfer of vaccine manufacturing process to the new manufacturing facility
• Partner with cross functional team to develop process/procedures and complete successful qualification of equipment/process.
• Provide technical expertise for unit operation for design reviews, process hazard assessments, quality risk assessments, factory and site acceptance testing, qualification
• Author and update technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstrations, and validation.
• Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings
• Support process improvement projects and complex manufacturing investigations
• Support digital and data integrity initiatives for the project
• Provide technical support to manufacturing for complex problems and issues
• Develop and assure consistent application of standardized work, engineering, and process tools
• Examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause
• Support regulatory submission preparation and inspections for the facility

Required Qualifications:

• Bachelor’s degree in an Engineering or Science Related field.
• Demonstrated a strong academic record and have excellent interpersonal and communication skills.

Preferred Qualifications:

• 0-2 years of experience in GMP manufacturing and/or technical support of GMP manufacturing operations.
• Experience in biologics, vaccine or bulk sterile manufacturing facilities
• Experience leading and managing departmental or cross-functional teams
• Regulatory inspection presentation experience with external regulatory authority representatives
• Strong understanding of process risk assessment tools, Quality by Design principles, and Lean/Six Sigma methodologies/certification

MMD2024

FTP2024

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

US and Puerto Rico Residents Only:

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.  This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R251696