Associate Director, Engineering

Job Description

If this position will be based in the US or Puerto Rico (not applicable to positions based outside of US or Puerto Rico): Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.

Our Engineers support internal manufacturing operations by ensuring they remain operational, and continuously improve and innovate the manufacturing process. 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.

At the Durham Vaccine Facility in Durham, North Carolina, the Vaccine Manufacturing Facility (VMF) Technology Team is seeking candidates to fill Integrated Process Team (IPT) Engineering positions to partner with Manufacturing Operations, Quality Operations and Process Automation. VMF Technology provides technical engineering and manufacturing support for the production of our Company's live virus vaccines at Durham.

The IPT (Integrated Process Team) Associate Director reports to the Site Technical Lead and will be part of a cross functional team charged with the technical support of the manufacturing shop floor in a fill-finish vaccine facility. This role requires the ability to manage 6-8 engineers and multiple projects and activities across the IPT. Strategic and effective communication and collaboration skills are essential. This leader will collaborate with their colleagues in Operations, Quality and Automation to ensure continuous supply of our necessary vaccines. The successful candidate will also have robust problem solving skills and a hands-on approach to equipment validation and problem solving, with a bias toward going to see problems for oneself in the field as they arise. Enthusiasm for continuously learning is a requirement.

Responsibilities

This role will serve as one of the Associate Directors within the Technical Engineering organization that will manage:

• A team of highly technical individual contributors and be responsible for all human resource activities including one-on-one meetings, team development, hiring, talent assessment and performance reviews

• Coordinated responses to process upsets, including short-term mitigation to return to service and assessment of product impact

• The prioritization of projects, timelines, and resource allocation to improve safety, compliance, stability, cost and capacity

• Approval of investigations, SOPs, change requests, continued process verifications, protocols, CAPAs, Quality Risk Assessments

• Support of regulatory audits with coaching Subject Matter Experts (SMEs) and presenting to auditors

Education

• Bachelor Degree in Engineering or Science

Required

• Minimum eight years in a technical role (6 Years with a Masters Degree or MBA; 4 years with a PhD)

• Strong planning, scheduling, and time management skills

• Working knowledge of regulatory requirements in accordance with GMP manufacturing operations

• Principled verbal and written communication skills

• Interacting with regulatory inspectors

• Familiarity with Change Control systems (i.e. Trackwise) | Equipment qualification and validation

Preferred

• In-depth knowledge of at least two of the following processes: sterile supply, media manufacture, equipment preparation, bulk formulation, vial filling, lyophilization, sealing, container inspection

• Sealing and container inspection knowledge

• Familiarity with process risk assessment tools and Lean/Six Sigma methodologies

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.

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.

Residents of Colorado

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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:

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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:

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Flexible Work Arrangements:

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Requisition ID:R142491