Lead Tech, Operations Lyophilization Night Shift

Job Description

This is a Night shift position, 12.5 hour (6:30 PM-6:30AM) rotation (2-2-3).•-

The Vaccine Manufacturing Facility Lead Technician is an excellent opportunity for highly motivated individuals with expertise working in aseptic production and manufacturing operations.•-The Lead Technician is a manager developmental role and will serve on the Operations leadership team.•-Key responsibilities of the Lead Technician include direct support of operations on the production floor, coordination across processing suites, real-time batch record review, execution of aseptic processing requirements as needed, adherence to Good Manufacturing Practices, and leading in a team environment to accomplish shift and departmental goals.•-The ideal candidate for this position has demonstrated the ability to manage their own work activities as well as activities of others, contributing toward the success of the team through the use of their decision-making and problem-solving skills and their knowledge of aseptic manufacturing.•-

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Responsibilities include, but are not limited to:•-

• Maintains qualification in the specified suite in the posting (at minimum).--
• Maintains gown qualification.-
• Assists Manager with coordination of daily work schedules, coordinates processing activities across suites, and effectively communicates performance targets.•-
• Assists Manager in leading a team-based culture through continuous improvement activities•-
• Assist Manager with facilitating shift change.•-
• Manages training progress of suite operators and assigns daily roles to support efficient training.-
• Observes critical processing steps and provides real-time feedback.•-
• Performs inventory control and cycle counts. Resolves and reports issues with product accountability and SAP system discrepancies.•-
• Executes real-time batch record review and ensures timely closure of shopfloor order.--
• Reviews and completes documentation to support production activities, including batch record events and management of forms and labels on the shop floor.•-
• Collaborates with stakeholders and customers to resolve production related issues•-
• Demonstrates a strong problem-solving ability to troubleshoot and communicate appropriately and effectively•-
• Conforms to established safety procedures in accordance with OSHA and other regulatory agencies•-
• Identifies and addresses compliance, environmental, safety, and process deviations as required and escalates to appropriate personnel.•-
• Attends and actively participates in safety & quality walkthroughs, 5S, kaizen events, or any other operations initiatives as required.•-
• Serves as a back-up to the Operations Coach on shift, as required.•-
• Serves as back-up to the Lead Tech, operational compliance role, as required.-

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Education Minimum Requirement:•-

• High School Diploma or equivalent is required for this position.•-

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Required Experience and Skills:•-

• Qualified in the suite specified to the posting.-
• At least four (4) years GMP manufacturing/processing experience or at least two (2) years GMP manufacturing/processing experience with a Bachelor's degree in Life Science or Engineering•-
• Must be willing to work 12-hour night shift (6:00PM-6:30AM) on a rotating 2-2-3 schedule.•-Note that this schedule does include working alternating weekends and holidays•-
• Must be able to successfully pass and maintain aseptic gowning qualification.•-Aseptic gowning requires that all skin and hair be covered through wearing the following: beard/mustache cover, hair net, hood and face mask, goggles, jumpsuit, gloves and boots.•-
• Must be willing to be qualified in aseptic operations and perform operator roles as needed.•-
• Must be willing and able to lift 50 lbs., bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator•-
• Must be willing to be vaccinated/blood tested for titer for products manufactured within the facility if needed.•-
• Computer literacy (internet browsers, e-mail, spreadsheets, word processing)•-
• Experience with batch record execution, including good documentation practices•-

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Preferred Experience and Skills:•-

• Bachelor's degree in Life Science or Engineering•-
• Associate's degree in Life Science or Engineering•-
• BioWorks Certificate (working in an FDA regulated industry)•-
• Environmental Monitoring and Sampling•-
• Proficiency in the use of SAP in a manufacturing setting•-
• Review of Electronic Batch Record•-
• Certified Yellow Belt/Green Belt•- MSJR #VetJobs #EBRG's

Required Skills:
Accountability, Accountability, Adaptability, Analytical Problem Solving, Aseptic Processing, Cleanroom Gowning, Cleanroom Operations, Communication, Computer Literacy, Data Analysis, Documentations, Environmental Monitoring, Environmental Sampling, Equipment Maintenance, GMP Compliance, Good Manufacturing Practices (GMP), Inventory Control Procedures, Inventory Management, Life Science, Master Batch Records, Operations Support, Process Optimization, Production Scheduling, Production Support, Regulatory Compliance {+ 4 more}

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:

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".

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, 2nd - Evening, 3rd - Night

Valid Driving License:
No

Hazardous Material(s):
Cleaning Solutions

Job Posting End Date:
11/26/2025
*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.

Requisition ID: R372807