Senior Specialist, Engineering

Job Description

Our Engineers support internal and external manufacturing operations, ensuring they 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.

Summary, Focus and Purpose

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

The GSEC Builders team is seeking a highly motivated individual to fill an open position to support the start-up of a new live virus vaccine filling and lyophilization facility. Facility start-up will include design, commissioning, equipment qualification and vaccine drug product process demonstration in support of facility licensure.

The Building 50 Live Virus Vaccine Drug Product Manufacturing 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 Senior Specialist, Technical Operations will be responsible for equipment and facility delivery as well as other process licensure activities in support of technical transfer of vaccine products to the new facility. This role will actively support, participate in, and embrace an empowered team culture. In this role, the Sr. Specialist will work as an individual contributor as well as a leader within a cross-functional group that includes Global Engineering Services, Technical Operations, West Point Operations, Quality, Automation, and others.

Key Functions:

• Lead technical initiatives associated with new facility startup and qualification in support of both product transfer(s) and commercial production of lyophilized LVV products.
• Partner with a cross functional team to develop processes/procedures and complete successful qualification of equipment/process.
• Provide technical expertise for unit operation for process hazard assessments, quality risk assessments, and qualification.
• Support execution of the technical transfer strategy of a live virus vaccine product to a new manufacturing facility.
• 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.

Education Requirements:

• Bachelor's degree in an Engineering or Science Related field with five years in GMP manufacturing and/or technical support of GMP manufacturing operations or
• Master's degree in an Engineering or Science Related field with four years in GMP manufacturing and/or technical support of GMP manufacturing operations

Required Experience and Skills:

• Demonstrated strong performance record and excellent project management skills.
• Principled verbal and written communications.
• Experience in biologics, vaccine or sterile manufacturing facilities.
• Highly developed communication, leadership and teamwork skills.

Preferred Experience and Skills:

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

Required Skills:
Adaptability, Change Control Processes, Customer-Oriented, Engineering Processes, Global Manufacturing, GMP Compliance, Good Manufacturing Practices (GMP), Manufacturing Process Validation, Oral Communications, Process Documentation, Process Optimization, Production Process Development, Project Management, Regulatory Compliance, Regulatory Submissions, Risk Control Assessment, Root Cause Analysis (RCA), Strategic Thinking, Teamwork, Technical Transfer, Written Communication

Preferred Skills:

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:

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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
$117,000.00 - $184,200.00

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:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
NA

Job Posting End Date:
01/29/2026
*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.