Job Description
We are seeking a dedicated manufacturing Operations Specialist to join our team, B63A Syringe Filling Facility in 2nd shift (3:30pm - 12:30am). In this role, you will lead the start-up of a new vaccine formulation and filling facility at our West Point site. Your leadership will be crucial in ensuring operational excellence and compliance with industry standards.
This role in our company's Manufacturing assures that products manufactured comply with cGMPs, operating procedures, and other applicable regulations.
The incumbent will:
Assist with the direct processing of materials and the associated hourly workforce to ensure attainment of business results.
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.
Resolve technical and personnel challenges.
Willing to accept the need for change; and has the ability to affect positive change, manage conflict and difficult discussions.
Support Value Stream, World Class Supply, Lead Time Reduction, Right First Time and waste reduction initiatives.
Create 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.
Support site, divisional and regulatory audits and inspections.
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.
Coordinate and complete optimization activities, in a multi-shift environment. 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.
Due to the high impact nature of this role, it is essential that the incumbent demonstrate integrity, credibility and flexibility in their daily performance so as to motivate others to do the same.
Assure compliance with safety and environmental practices, cGMPs and SOPs in the work area.
Initiate investigations when a quality or safety event occurs during the shift. Work with members from Quality and Technical Operations to properly handle unplanned events.
Ensure materials receiving and verification in the work area, equipment cleaning, set-up and area cleaning and verification are completed according to procedures.
Job Opportunity: Manufacturing Operations Specialist (2nd Shift)
We are looking for a dedicated Manufacturing Operations Specialist to join our team at the B63A Syringe Filling Facility for the 2nd shift (3:30 PM - 12:30 AM). In this role, you will play a key part in starting up a new vaccine formulation and filling facility at our West Point site. Your leadership will help ensure our operations run smoothly and meet industry standards.
Key Responsibilities:
Operational Compliance: Ensure our products meet current Good Manufacturing Practices (cGMPs), operating procedures, and all relevant regulations.
Team Leadership:
Direct the processing of materials and manage the hourly workforce to achieve business goals.
Collaborate and motivate your team, coordinating tasks and preparing equipment and work areas.
Problem Solving:
Address technical and personnel challenges effectively.
Embrace change and lead positive transformations, managing conflicts and difficult conversations.
Continuous Improvement:
Support initiatives focused on reducing lead times, waste, and improving efficiency, quality, and overall operational excellence.
Documentation Creation:
Develop Standard Operating Procedures (SOPs), Standard Work Documents, Electronic Logs (E-Logs), Manufacturing Batch Records, e-learning courses, and training materials.
Employee Training:
Participate in training employees and qualifying equipment and facilities as necessary.
Audit Support:
Support site, divisional, and regulatory audits and inspections.
Collaboration for Improvement:
Work with team members to implement continuous improvement initiatives, focusing on cost savings, productivity, energy conservation, and lean practices.
Optimization Coordination:
Coordinate and complete optimization activities in a multi-shift environment.
Lean and Six Sigma:
Apply lean principles and Six Sigma methods to solve problems collaboratively.
Corrective Actions:
Facilitate the implementation of corrective actions for past performance issues and identify safety and quality trends.
Financial Savings:
Recognize and investigate opportunities for financial savings.
Integrity and Compliance:
Display integrity, credibility, and flexibility in your role to inspire the same in others.
Safety Practices:
Ensure compliance with safety and environmental practices, cGMPs, and SOPs in your work area.
Incident Management:
Initiate investigations if a quality or safety issue arises during your shift.
Collaborate with Quality and Technical Operations teams to manage unplanned events.
Material Handling:
Ensure proper receiving and verification of materials, as well as equipment cleaning and area preparation, according to established procedure
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
Willingness to work alternate shifts and weekends during special circumstances and critical business needs.
Good verbal and written communication skills
Ability to enact conflict resolution
Ability to effectively respond to change
Excellent analytical and organizational skills
High personal integrity, credibility and energy
Computer literacy in MS Office, Word, Outlook, Excel
Preferred Experience and Skills:
Minimum of 1 years of experience working in/or supporting manufacturing in cGMP Operations
Experience with Lean Production and Lean Management Systems
Experience with SAP or similar ERP software
#MSJR
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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.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.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 diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
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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:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
2nd - Evening
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
03/19/2025
*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.
