Lead Operations Technician - Purification

Job Description

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

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.

The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility established in 2004, manufactures our Company lifesaving vaccines in bulk and finished forms. Due to the importance of this facility in our Company Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1,000+ people.

The Durham site is supporting the expansion of Gardasil vaccine manufacturing to help eradicate HPV-related cancers. Members of the Operations team in this new and exciting facility will have the unique opportunity to experience the design process, commissioning and qualification, licensure, and ramp up to full production.

Durham’s Lead Technician, Operations will be a leader with strong interpersonal, communication, and collaboration skills responsible for leads peers in supporting the manufacturing process. Individual will possess the ability to lead a team, train others and contribute to and implement process improvements.

This position will support either Fermentation, Purification, Alum Adjuvant, or Sterile Supply production. Position will start as Monday-Friday during the project phase and transition to shift. 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 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.

• Author, review, and/or edit procedures and technical documents to support regulatory filings including standard operating procedures, job aides, and learning documents.

• 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.

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

• Performs sampling/in-process testing supporting the manufacturing and validation process for current process as well as developmental work for new products/processes as required independently.

• 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.

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

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

• Ability to effectively coach new trainees to build their skills so that they may become effective operations technicians and SMEs.

• Analyzing and implementing initiatives, training programs, and systems that will help to increase overall success within the department.

• Participate in training for new hire training programs.

Education Minimum Requirement:

• High School Diploma/GED or higher

Required Experience and Skills:

• Minimum (4) four-years 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 (General):

• Demonstrated 2-4 years of leadership experience

• Minimum Associates Degree in science or related field

• Applicable mechanical and project management experience

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

• Experience training others and/or leading hands-on or instructor-led training

• Demonstrated knowledge of Lean Six Sigma/MPS principles

• 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

• Strong collaboration, communication, and leadership skills

• Extensive Anion chromatography and large scale column packing experience

• Manufacturing Buffers (small and large scale) with pH and Conductivity adjustments

• Proficient with ultrafiltration / diafiltration (UFDF) using TFF skids

• Sterile filtration into final bulk

• Experience with CIP/SIP of tanks and associated piping

Travel: Up to 25% of the time

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed 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 …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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.

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

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., 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R173748