Director, Technical Operations Engineering

Job Description

Our Engineers support internal and external manufacturing operations to build, develop, operate, and continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Position Description:

The Director, Engineering is the lead for technical operations engineering programs across the facility, including equipment readiness, process support, deviation management, and sterility assurance for a capital project start-up in Durham, North Carolina. The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and utilities. The Director is accountable for building and leading the technical operations team and strategic direction, as well as providing communication across various stakeholders to establish and improve the facility, equipment, and process. This role is a member of the facility leadership team.

The responsibilities of the Director include but are not limited to:

• Developing, owning and executing the technical strategic direction for the facility, including technical improvements, deviation management, and technical operations process

• Coaching and developing a team of people managers, Engineers, and Scientists

• Technical ownership for new projects and equipment

• Directing routine process support and improvement activities

• Serving as technical SME during regulatory inspections and audits

• Providing technical guidance for start-up and production support, projects, deviations and changes.

• Contributing to the facility leadership team, owning tech ops strategy, and guiding facility operations

Required Education, Experience and Skills:

• Bachelor’s degree in Engineering, Science, or related field AND at least ten (10) years of working in the Manufacturing, Pharma, Biotech, and/or Vaccines industry OR

• A Master's Degree AND at least eight (8) years of working in the Manufacturing, Pharma, Biotech, and/or Vaccines industry OR

• A Doctorate degree AND at least five (5) years of working in the Manufacturing, Pharma, Biotech, and/or Vaccines industry

• Experience managing a team, including coaching and developing people

Preferred Experience and Skills:

• Experience with technical operations, tech transfer, capital projects, facility start-up, production support, and improvement projects

• Experience with aseptic processing operations such as bulk production, formulation, vial filling, and lyophilization, and supporting clean utilities

• Strategic, end-to-end thinking

• Experience in regulated or Good Manufacturing Practice (GMP) manufacturing and/or technical support of manufacturing operations

• Familiarity with change control systems and technical assessment of change in a current Good Manufacturing Practice (cGMP) production environment

• Experience with deviation management and associated systems

• Experience with sterile processing and sterility assurance practices and guidelines

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 …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

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.

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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., 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R124892