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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.

Position Description

This is a** **day/night shift position, 12.5 hour (** **6:00 AM - 6:30 PM; 6:00PM-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.

**Responsibilities include, but are not limited to** :

+ Executes operational review and comment resolution of batch records to include binder assembly.

+ Maintains gown qualification.

+ Maintains qualification within at least 1 suite

+ Reviews and completes documentation to support production activities, including batch record events and management of forms and labels on the shop floor.

+ Assist with label preparation (e.g., GLIMS, Release) for upcoming production

+ Executes operation sample management of samples handled within Durham

Review special communications at shift change to include 4-Quad.

+ Executes room incursion initiation and approvals

+ Assists Manager in leading a team-based culture through continuous improvement activities

+ Assist Manager with facilitating shift change.

+ Performs inventory control and cycle counts. Resolves and reports issues with product accountability and SAP system discrepancies.

+ Assists team in real-time batch record review and ensures timely closure of shopfloor order.

+ 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. .

+ Serves as a back-up to the Operations Coach on shift, as required.

+ Serves as back-up to the suite O4 or other missing role to support daily processing activities, as required.

Education Minimum Requirement:

+ High School Diploma or equivalent is required for this position.

+ Associate's or Bachelor’s degree in Life Science or Engineering preferred.

Required Experience and Skills:

+ Qualified in at least 1 manufacturing area.

+ Technical writing experience, i.e. investigations, change requests, standard operating procedures, batch records, protocols.

+ Must be able to work both independently and within multi-functional teams in a fast-paced environment.

+ Experience with pharmaceutical process systems including PAS-X, DeltaV, SAP, RtReports, GLIMS

+ 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 day/night shift (6:00 AM to 6:30 PM; 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

Preferred Experience and Skills:

+ 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

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) 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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)

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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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:

1st - Day, 3rd - Night

Valid Driving License:

No

Hazardous Material(s):

N/A

Required Skills:

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

Preferred Skills:

Job Posting End Date:

09/25/2025

*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:** R364887