Job Description

Our Engineers support internal and external manufacturing operations 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 Bulk organization is seeking a highly motivated individual for a Specialist – Engineering position within the Technical Operations team. The successful candidate will have the opportunity to contribute to the performance and results of the manufacturing area by providing technical guidance and anticipating and interpreting customer needs to identify and implement solutions.

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 Specialist will work as an individual contributor as well as a team within a cross-functional group that includes Operations, Quality, Automation, Maintenance and others. The primary responsibility of the candidate will be to develop tools to monitor process data associated with the manufacturing process.

Additional responsibilities include:

• Provides technical support for bulk manufacturing at West Point to align with department, site, and franchise objectives.

• Provides on-the-floor support for complex operational and technical (process/equipment) issues.

• Leads or works as a team member on projects to improve the performance of our processes, including complex investigations, corrective/preventative actions (CAPAs) and equipment validation/qualification.

• Develops and authors technical and manufacturing documents for investigations, process design/definition/qualification/validation, change control, annual product reviews, standard operating procedures (SOPs), batch records, and preventative maintenance.

• Monitors the health of the process through continuous process monitoring, communicating observations proactively to stakeholders.

• Prepare documentation to support regulatory submission and participate in regulatory inspection activities for the facility.

• Applies a continuous learning mindset to maintain a high level of technical process and system knowledge, enabling success with core responsibilities.

• Manages project work to ensure due dates are met, escalating when necessary and developing remediation plans.

• Assures consistent application of standardized work, engineering and process tools.

• Promotes open communications and teamwork. Effectively collaborates with cross-functional peers.

• Supports safety, environmental, and compliance initiatives.

• Examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve manufacturing challenges.

Education Minimum Requirement:

• B.S. degree in Engineering or Sciences.

• Minimum 2 years post-bachelor’s degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations

Required Experience and Skills:

• Strong problem-solving skills.

• Developed communication, leadership and teamwork skills.

• Ability to manage projects/work to ensure timely completion.

Preferred Experience and Skills:

• Experience with data analysis (JMP, Spotfire, Pipeline Pilot)

• Experience in change control and/or deviation management and/or equipment support and/or project support role.

• Experience in biologics, vaccine or bulk sterile manufacturing facilities.

• Understanding of sterile and aseptic processing

• Proficient in the following competencies: flexibility, motivation, teamwork/collaboration, problem-solving, and project management.

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:

EEOC Know Your Rights

EEOC GINA Supplement​

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.

Learn more about your rights, including under California, Colorado and other US State Acts

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, Monday - 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”.

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:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/17/2025

*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.

Requisition ID:R348680