Job Description
This position is in direct support of our Sterile Supply manufacturing process for Bulk Drug Substance. Focused areas of responsibility include but are not limited to activities of: Component Assembly, GMP Autoclaves, Dry Heat Ovens, Parts Washers, and area cleaning.
Responsibilities may include but are not limited to;
Support operations production through start-up and commissioning and qualification through licensure and ramp up.
Working in conjunction with all appropriate personnel, performs manual and automated operations, general maintenance and support functions necessary for production.
Provides and/or authors all documentation and clerical functions necessary to allow proper accountability and traceability of product.
Maintains, inventories, and transports all required equipment, materials, supplies and products. Ensures shipment criteria and timely availability and delivery.
Performs general maintenance and assists or ability in troubleshooting of equipment independently.
Performs housekeeping in all work areas. Executes facility decontamination according to procedures. Maintains, cleans and prepares equipment used in production.
Performs sampling/in-process testing supporting the manufacturing and validation process for current process.
Provides timely delivery of sample and other materials as required to appropriate laboratories, coordinating with Quality and Logistics as required.
Attends and actively participates in HAZOPS, waste walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required.
Self-motivated to maintain own training status and ability to train others.
Participate in document design activities working alongside operations team members to develop reliable, consistent manufacturing processes that meet cGMP requirements.
Travel : 0%
Position Qualifications:
Education Minimum Requirement:
Required Experience and Skills:
1 year of manufacturing work experience or Associates Degree in science or related field in lieu of experience.
Demonstrated written and verbal communications skills
Must be willing and able to lift 50 lbs and work on elevated platforms
Must be willing to work 12-hour shifts:
If day position hours will be 7am-7pm.
If night position hours will be 7pm-7am.
Must be willing to work a 2-2-3 schedule (2 days on, 2 days off, 3 days on) which includes every other weekend.
Preferred Experience and Skills:
Bioworks Certificate in addition to minimum required experience and skills.
Experience training others through hands-on training
Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements
Demonstrated ability to work both independently and as a part of a team
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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.
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)
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EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
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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.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
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-.
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:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
NA
Job Posting End Date:
10/15/2024
*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.
Job Posting End Date: 10/15/2024
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: R311715
