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 of our company's vaccine products and is growing to meet the vaccine demands of the future.

The Building 50 Live Virus Vaccine Filling Facility Project team is seeking a highly motivated individual to fill an open position to lead the start-up of a new vaccine filling & lyophilization facility at the West Point site. Facility start-up will include design, commissioning, equipment qualification and live virus vaccine drug product process demonstration in support of facility licensure.

The Specialist, Operations will be an energetic team member with strong collaboration skills responsible for partnering with multiple functions to execute facility startup and operational readiness on 1st Shift. This is targeted for an individual with an interest to growing into an operations management role with impact directing an operator workforce and the daily execution in the facility. Key responsibilities of the role include:

• Provide operational & technical expertise for design reviews, process hazard assessments, quality risk assessments, factory and site acceptance testing, performance qualification, and operational training.

• Support digital and data integrity initiatives for the project.

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

• Examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause.

• Support regulatory submission preparation and inspections for the facility.

• Assist with the direct processing of materials and the associated hourly workforce to ensure attainment of business results.

• Lead shop floor activities and training efforts to support operational requirements.

• Effectively collaborate with a work team while motivating others, ensuring performance, schedule execution, task coordination, equipment and area preparation and effective administration of personnel policies and procedures.

• Create and maintain SOP’s, Standard Work Documents, E-Logs, Manufacturing Batch Records, E-learning courses and training materials to support the manufacturing area.

• Participate in training of employees and qualification of the equipment and facilities as required.

• Assure compliance with safety and environmental practices, cGMPs and SOPs in the work area.

Because our business is dynamic and advances in science and technology require new methods of production, we are looking for individuals who can do the following:

• Collaborate with team members to implement continuous improvement initiatives.

• Support activities in the areas of cost containment, efficiency, productivity, energy conservation, waste minimization, operational excellence and lean practices.

• Utilize lean principles and six sigma methodology to solve problems while working in teams.

• Facilitate implementation of corrective actions to correct past performance, proactively identify safety and quality-related trends.

• Recognize and investigate opportunities for financial savings.

• Ability to execute and lead process shakedowns, development, and training events on the shop floor.

Qualifications:

Minimum Required Education, Experience and Skills:

• Bachelor’s degree or higher, preferably in Science, Engineering, Business Administration, or another technical field

OR

• High School Diploma/GED with four (4) years of relevant experience in manufacturing or military service

AND

• Willing and able to work off-shifts and weekends as needed

Required:

• Minimum of one (1) year of GMP manufacturing experience or other heavily regulated industry (example: FDA, military, nuclear, and petro-chemical)

• Strong planning, scheduling, analytical and time management skills

Preferred:

• Minimum of two (2) years of experience in relevant manufacturing or processing (aseptic/sterile, bulk, solid oral dosage, packaging, etc.) or a heavily regulated industry

• Lean Manufacturing experience

• Facility startup experience or new process development

• Willingness and Ability to support off-shift work

In accordance with Policy 82 – Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in their current position prior to applying for open positions.

#MSJR

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”.

The salary range for this role is

$77,700.00 - $122,300.00

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Adaptability, cGMP Compliance, Computer Literacy, Corrective Action Management, Data Analysis, Environmental Health and Safety (EHS) Management, Equipment Set Up, GMP Compliance, Lean Manufacturing Tools, Manufacturing Support, Motivating Teams, Operational Excellence, Process Monitoring, Process Optimization, Process Troubleshooting, Quality Risk Assessment, Regulatory Compliance, Safety Compliance, Safety Standards, Task Coordination, Teamwork, Training and Development

Preferred Skills:

Job Posting End Date:

07/10/2025

*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.