Job Description
Our Manufacturing Operations teams are the people that make therapies for our patients. We work in the manufacturing plants with a "Safety First, Quality Always" mindset, striving for continuous improvement, and earn our right to produce. We work in local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and finished products.
This role is within a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse. As the team finishes design and construction of the facility, the Lead Technician will play a critical role in supporting the Global Engineering Services team, partnering with internal stakeholders, and building the operations team who will take ownership of the facility. Members of the Operations team in this new and exciting facility will have the unique opportunity to give input in the design process, startup their areas, and lead the teams to full production.
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Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Responsibilities may include but are not limited to;
Project Support
- Supports project team as operations expert through start-up, commissioning, qualification through licensure and ramp up of facility.
- Author, review, and/or edit operations and technical documentation (Batch Records, SOPs, Job Aides, training, and engineering documents) to support project and future operations.
- Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while coordinating with appropriate personnel.
- Actively participate in team meetings HAZOPS, waste walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required.
NOTE:
1) Position REQUIRES chest X-ray and TB Titer and offer extension is contingent upon passing medical results
2) Position is scheduled for Monday - Friday, 6:00am - 2:30pm
Operational Expertise
- Competent execution and ownership to meet production targets for area within responsibility including:
- Attending and escalation of concerns or needs at daily huddles and as needed
- Cleaning, setup, operation and troubleshooting of equipment and facilities
- Execute duties in a safe and compliant manner
- Uphold training standards
- Maintenance of excellent recordkeeping and housekeeping
- Work in a team environment
- Drives culture of continuous improvement. Implements and raises ideas to increase success of group
- Participates on and/or performs activities to support technical and OPEX functions such as Kaizen events, ad-hoc sampling, or protocol execution.
- Maintains detailed knowledge of equipment and processes.
- Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while notifying appropriate personnel.
Education Minimum Requirement:
- High School Diploma/GED or higher
Required Experience and Skills:
- At least two (2) years GMP manufacturing/processing experience, or a Bachelor's degree in Life Science or Engineering
- Demonstrated written and verbal communications skills
- Computer literacy (internet browsers, e-mail, spreadsheets, word processing)
- Must be willing and able to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator
- Successful completion of TB titer and Chest X-ray are required.
Preferred Experience and Skills (General):
- Minimum Associates Degree in Science or related field
- Bioworks Certificate (working in an FDA or similar regulated industry)
- Applicable mechanical and project management experience
- Experience with automated systems (MES, SAP, DeltaV, or similar)
- Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements and Good Documentation Practices (GDP)
- Demonstrated ability to work both independently and as a part of a team
The following experience is a significant advantage for a Senior Technician supporting Production Support and Media Operations:
- Grade C/D gowning
- Parts washer and autoclave operations
- Media Formulation and dispensing
- Weigh and Dispense of raw materials, liquid and powders
- Cleaning of graded spaces
- Previous leadership experience
- Maintaining equipment inventories
Travel: Up to 10% of the time
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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".
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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.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
11/21/2024
*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:R320710