Lead Operations Technician - Durham, NC Old Oxford

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 product manufacturing including aseptic filling, lyophilization, and visual inspection utilizing highly automated machines in regulated, clean room environments complying with current Good Manufacturing Practices.

Key Responsibilities

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

• 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

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

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

• Conducts and completes 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

• High School Diploma/GED or higher

Experience and Skills

Required

• Minimum 4 years' relevant work experience in GMP environment

• Principled written and verbal communications skills

• 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)

• Able to lift 50 lbs., bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator

• Successful completion of TB titer and Chest X-ray

• Aseptic filling operations

• Grade A isolator containment systems

• Lyophilization

• Autoclaves, washers, and dry heat ovens

Preferred

• 2 to 4 years in a leadership role

• Minimum 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

• 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

Scheduled Requirements

• 1st Shift Monday to Friday | Shift schedule may change when operations starts, expected in 2023

Travel Requirements

• Up to 15% of the time

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals 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.

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.

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

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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:R182846