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Merck
Durham, North Carolina, United States
17 hours ago

Description


Job Description

New Hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for Covid-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.

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.

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.

The ideal candidate for this role will be a task and relationship focused leader who maximizes the potential of all team members, collaborates effectively with support groups, and has demonstrated the ability to meet immediate business objectives even through adversity. This role will support drug substance manufacturing/sterile supply in regulated, clean room environments complying with current Good Manufacturing Practices.

Responsibilities may include but are not limited to;

Project Support:
  • Supports project team as operations leader 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 Aids, training, and engineering documents) to support project and ongoing 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.
  • Assists operations team with development of daily work schedules, coordinates processing activities across suites, and effectively communicates performance targets with group.
  • Develop and participate in training programs for new hires, continue program into operations.


Operational Leadership:
  • Leads & coordinates team in execution of daily floor activities including daily huddles, assignment of duties, troubleshooting, and coaching.
  • As part of operations leadership, continuously monitors shift schedule and coordinate personnel needs with management.
  • Actively promotes and maintains a culture of excellence, safety first, quality always, mindset by maintaining records, housekeeping, compliance, and measurement of performance.
  • Drives culture of continuous improvement. Implements and raises ideas to increase success.
  • Coordinates or performs activities to support technical and OPEX functions such as Kaizen events, sampling, or protocol execution.
  • Maintains detailed knowledge of equipment and processes, can act as SME for department when interfacing with stakeholders or regulatory agencies.
  • Issues production documentation to floor and ensure traceability and completeness of records.
  • Performs inventory control and cycle counts. Resolves and reports issues with product accountability and SAP system discrepancies.
  • Executes real-time batch record review and is responsible for alarm monitoring and reconciliation.
  • Demonstrates a strong problem-solving ability to troubleshoot and communicate appropriately and effectively.
  • 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:
  • Minimum four-year relevant work experience in GMP environment.
  • Demonstrated written and verbal communications skills.
  • Must be able to successfully pass and maintain aseptic gowning qualifications. Aseptic gowning requires that all skin and hair be covered through wearing the following: beard/mustache cover, hair net, hood and facemask, goggles, jumpsuit, gloves, and boots.
  • 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.
  • Perform operator roles as needed.
  • The position will initially be Mon-Fri, day shift. Shift schedule may change when operations starts, expected in 2023.
  • Successful completion of TB blood test and chest x-ray are required.


Preferred Experience and Skills (General):
  • Demonstrated 2-4 years of leadership experience.
  • Associates Degree in science or related field.
  • Applicable mechanical and project management experience.
  • Proficiency with automated systems (MES, SAP, DeltaV, or similar).
  • Experience training others and/or leading hands-on or instructor-led training.
  • Demonstrated knowledge of Lean Six Sigma 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.


A Lead Technician supporting Drug Substance/Sterile Supply operations would have the following preferred experience:
  • Aseptic drug substance experience: Bio Safety Cabinets, cRABS.
  • Media preparation and sterilization.
  • Experience with autoclaves, washers, and incubators.


Travel:
  • Up to 15% of the time.


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 that's 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 ...

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. TechnicianDurham


    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., 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:
    10%

    Flexible Work Arrangements:
    Not Specified

    Shift:
    1st - Day

    Valid Driving License:

    Hazardous Material(s):

    Number of Openings:
    2

    Requisition ID:R159777


    Job Information

    • Job ID: 61130274
    • Location:
      Durham, North Carolina, United States
    • Position Title: Lead Tech, Operations
    • Company Name: Merck
    • Job Function: Other
    • Job Type: Full-Time
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