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Lead Technician - O4

Merck

Merck

Durham, NC, USA
Posted on Saturday, June 1, 2024

Job Description

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.

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 will change to second shift when operations start, expected in Q4 2024. Team is currently working augmented shift to support Project timelines.

  • 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 would have the following preferred experience:

  • Aseptic drug substance experience: cRABS, Aseptic Techniques.

Travel: Up to 15% of the time

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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA 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.

Learn more about your rights, including under California, Colorado and other US State Acts

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, generally Tuesday, Wednesday and either Monday or 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”.

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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

2nd - Evening

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

06/15/2024

*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.


Job Posting End Date:06/15/2024


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:R296660