This is a Night shift position, 12.5 hour 6:00PM-6:30AM rotation (2-2-3).
The Vaccine Manufacturing Facility Senior Production Technician is an excellent opportunity for highly trained individuals with expertise working in aseptic production and manufacturing operations. The individual in this position will support the Vaccine manufacturing process through hands on processing activities. Key responsibilities for the Senior Production Technician include the execution of aseptic processing requirements, adherence to Good Manufacturing Practices, and working in a self-directed 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 act as a key contributor toward the success of the team using their decision-making and problem-solving skills and their knowledge of aseptic manufacturing.
Responsibilities include, but are not limited to:
Works collaboratively with all operations and support personnel, performing manual and automated processing of vaccine manufacturing equipment, performing general troubleshooting tasks, and supporting functions necessary to produce vaccines.
Executes all documentation and clerical functions necessary for proper accountability and trace ability of product.
Maintains, inventories, and transports all required processing equipment, materials, supplies and products needed to support manufacturing.
Operates various computer-controlled process support/process equipment (i.e. washer, autoclave, vial filler, lyophilizer, capping/inspect machines, etc.).
Performs process troubleshooting while maintaining production schedule
Executes equipment setup/breakdown, operational, and equipment inspections, as required
Assists Maintenance, Instrumentation and Automation during troubleshooting of common faults/errors
Performs housekeeping in all work areas. Executes facility sanitization and decontamination according to approved procedures.
Completes in-process testing and inspections supporting the vaccine manufacturing, validation, and development processes as required.
Identifies and addresses compliance, environmental, safety, and process deviations as appropriate and escalates to appropriate personnel.
Maintains, cleans and prepares equipment used in vaccine manufacturing process.
Schedules and performs environmental monitoring during processing and records results in the computerized database system. Provides timely delivery of samples and other materials as required to appropriate laboratories, coordinating with Quality and Logistics as required.
Attends and actively participates in safety & housekeeping walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required.
Serves on safety, quality and other committees as required.
Serves as the subject matter expert within the processing suite and trains new team members
Education Minimum Requirement:
High School Diploma or equivalent
Required Experience and Skills:
At least two (2) years GMP manufacturing/processing experience, or a Bachelor’s degree in Life Science or Engineering
Must be willing to work 12-hour day shift (6:00 AM to 6:30 PM) 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 facemask, goggles, jumpsuit, gloves and boots.
Must be willing and able to lift 50 lbs., bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator
Must be willing to work various shifts
Computer literacy (internet browsers, e-mail, spreadsheets, word processing)
Experience with batch record execution, including good documentation practices
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)
Certified Yellow Belt
Environmental Monitoring and Sampling
Proficiency in the use of SAP in a manufacturing setting
Execution of Electronic Batch Records
NOTICE FOR INTERNAL APPLICANTS
In 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.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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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, generally Tuesday, Wednesday and either Monday or 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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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.
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