Job DescriptionOur 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, Quality, Site Automation, and others.
Position Responsibilities:- Leads and/or works as a technical leader on process initiatives associated with the product transfer(s) and/or commercial production.
- Set and drive strategic 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 year's experience in a GMP (good manufacturing practices) manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree with < 4 year experience).
- Demonstrated a strong performance record and have excellent project management skills.
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
NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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U.S. Hybrid Work ModelEffective 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".
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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:1st - Day
Valid Driving License:No
Hazardous Material(s):n/a
Job Posting End Date:10/28/2024
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