Job Description

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 linked to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

Durhams Senior Technician, Operations will be an energetic leader with strong interpersonal, communication, and partnership skills accountable for supporting the manufacturing process. Individual will possess the ability to lead a small team, train others and contribute to process improvements.

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, including Purification, Fermentation, and Sterile Assembly/Supply. Off-shift and weekend coverage will be required based on business unit needs and specific assignments.

Responsibilities

* Support operations production through start-up and commissioning and qualification through licensure and ramp up

* Participate in document design activities working alongside operations team members to develop reliable, consistent manufacturing processes that meet cGMP requirements

* Promote a culture of visibility and accuracy of the project schedule and update dashboards accordingly to highlight project status to critical milestones

* Working in conjunction with all appropriate personnel, performs manual and automated operations, general maintenance and support functions necessary for the 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 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

* Performs housekeeping in all work areas | Implements facility decontamination according to procedures. Maintains, cleans and prepares equipment used in production

* Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while notifying appropriate personnel

* Serves on safety, quality and other committees as required

* Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process

* 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

* Works independently | Trains others | Identify and Problem Solve | Subject Matter Expert in automated systems (SAP, MES, DeltaV)

Education Requirement

* High School Diploma/GED or higher

Experience and Skills

Required

* Minimum three year relevant work in GMP environment

* Effective written and verbal communications skills

* Able to lift 50 lbs.



Preferred

* Demonstrated one to two years of leadership

* Minimum Associates Degree in science or related field

* Applicable mechanical and project management experience

* Proficiency with automated systems (MES, SAP, DeltaV)

* Training others and/or leading hands-on or instructor-led training

* On-the-floor cGMP manufacturing and familiarity with regulatory requirements

* Demonstrated ability to work both independently and as a part of a team

Work Schedule and Hours

* 12-hour shifts, including evenings (7pm - 7am)

* Rotating 2-2-3 schedule (2 days on, 2 days off, 3 days on) which may include weekends

DurhamTech

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network thats devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.

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:R103115