Lead Technician, Operations

Job Description

Our Manufacturing Operations teams are the people that make our lifesaving 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, start up their areas, and lead the teams into 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 product manufacturing including aseptic filling, lyophilization, and visual inspection utilizing highly automated machines 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 aides, training programs, 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 participates 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, adhoc sampling, or protocol execution.

• Maintains detailed knowledge of equipment and processes, can act as SME for department when interfacing with stakeholders or regulator 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.

• 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 willing and able to lift 50 lbs

• The position will initially be Mon-Fri, day shift. Shift schedule may change when operations starts, expected in 2023.

• Perform operator roles as needed.

• 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.

• 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 Product operations would have the following preferred experience:

• Aseptic filling operations

• Grade A isolator containment systems

• Lyophilization

• Visual inspection of product in glass vials including manual & automated techniques

• Experience with autoclaves, washers, and dry heat ovens

Travel: Up to 15% 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.

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R127426