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.

Durham’s Technician, Operations will be responsible for supporting the manufacturing process through hands on production in fermentation and purification processes, as well as sterile assembly and supply.

This position will support the vaccine drug substance site readiness, commissioning and qualification through licensure and ramp up to full production. This position will support all Operations areas. Off-shift and weekend coverage will be required based on business unit needs and specific assignments.

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.

Education Minimum Requirement:

• High School Diploma/GED or higher

Required Experience and Skills:

• Minimum 1-year relevant work experience in GMP environment
• 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, including evenings (7pm – 7am)
• Must be willing to work a rotating 2-2-3 schedule (2 days on, 2 days off, 3 days on) which may include weekends

Preferred Experience and Skills:

• Minimum Associates Degree in science or related field (or BioWorks Certificate)
• 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

Travel: 0%

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.

Pay Transparency Nondiscrimination

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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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 Specified

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Number of Openings:

3

Requisition ID:R125834