Senior Specialist, Engineering

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

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 Company 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 support 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 Sr. Specialist, Engineering is responsible for supporting process transfer(s), process qualification(s) and the associated technical / equipment initiatives in support of vaccine manufacturing unit operations while actively supporting, participating in, and embracing an empowered team culture. In this role, the Sr. 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, Site Quality, Site Automation, and others.

Position Responsibilities:

• Works as a technical leader on process initiatives associated with the product transfer(s) and/or commercial production.
• Set and drive strategic and/or tactical initiatives associated with process transfer(s)
• Support the facilitation of tactical initiatives associated with process design/definition, engineering studies, process simulations, process demonstrations, change control and qualification.
• Author and update technical and manufacturing documents necessary for process design/definition, engineering studies, process simulations, process demonstrations, change control and qualification.
• Develop and execute process change control(s) 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.
• Provide technical support to manufacturing for complex problems and issues.
• 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) in order to best understand and resolve the root cause.
• Support regulatory submission preparation and inspections for the facility.

Education Minimum Requirement:

• Bachelor's degree in an Engineering, Science, or Related field
• Minimum 5 years experience in a GMP (good manufacturing practices) manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree with < 4 year experience).

Required Experience and Skills:

• Demonstrated strong performance record and excellent project management skills.
• Strong communication, collaboration skills and ability to drive accountability.
• Experience in biologics, vaccine or bulk sterile manufacturing facilities.
• Principled verbal and written communications.

Preferred Experience and Skills:

• Experience leading and managing departmental or cross-functional teams
• Experience in technology transfer and/or facility start-up projects
• Strong understanding of process risk assessment tools, Quality by Design principles, and Lean/Six Sigma methodologies.
• Regulatory inspection presentation experience with external regulatory authority representatives

Our Manufacturing & Supply Division is committed to be the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.

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
$114,700.00 - $180,500.00

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 ;br>
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:
10%

Flexible Work Arrangements:
Hybrid

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/s

Required Skills:
Adaptability, Data Analysis, Detail-Oriented, Good Manufacturing Practices (GMP), Process Design, Process Hazard Analysis (PHA), Process Optimization, Root Cause Analysis (RCA), Strategic Thinking, Technical Leadership, Technical Problem-Solving, Technical Writing

Preferred Skills:

Job Posting End Date:
07/29/2025
*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.