Associate Director, Engineering

Job Description

Our Engineers support internal and external manufacturing operations remain operational, 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 Vaccines Operating Unit at our Company is undergoing significant growth across multiple product franchises at the West Point, PA site. The Associate Director, Engineering, will be responsible for the management and oversight of a project engineering team within Rotateq® End-to-End (E2E) Technical Operations, at the West Point site.

As the project team leader, the incumbent will be responsible for leading the broader technical team in the execution of portfolio of projects and initiatives spanning multiple product franchises across drug substance, drug product, and packaging operations. The Associate Director will have overall responsibility for the performance and results of the technical operations project engineering team and oversee execution of change control for capital projects, new product introductions, and implementation of continuous improvements to processes and equipment. In this role, the project team leader will be responsible for managing a team of scientists and engineers and maintaining an empowered team culture with a focus on employee growth and development.

• Reports to Director, Rotateq E2E Technical Operations, and drives department strategy, goals and objectives.

• Manage the E2E project portfolio, including communication of project status to leadership and various stakeholders.

• Lead the broader team in the utilization of standard project management approaches and assemble and lead teams in the execution of projects with responsibility of resourcing, charter development, project planning and tracking, risk management and escalation. The incumbent will operate with a high degree of independence, assuring alignment with appropriate functional leaders and stakeholders while advancing the team’s assigned projects and initiatives. The incumbent will collaborate and engage with multiple functional organizations such as Operations, Technology, Quality, Automation, Global Engineering Services, Procurement, Finance, Above Site Technology, Regulatory, among others, to develop and maintain processes that meet cGMP and business requirements.

• Manage team resources and prioritizes as aligned with business needs to include project support, and continuous improvement activities – e.g. improve safety/compliance, reduce cost and increase consistency and efficiency. Recruit and hire team members as necessary.

• Provides technical guidance to staff, colleagues or customers as well as anticipates and interprets the customer needs to identify solutions. Includes approval of technical documentation including protocols, qualification, change control, validation etc. as required. Responsible for presenting technical discussions to regulatory agencies during inspections.

• Direct working teams in the development of technical standards and approaches, technical capability building and provide leadership in leveraging digital and lean six sigma methodologies. Develop and assures consistent application of standardized work, engineering and process tools.

• Build talent by coaching and developing the members of the Technical Operations team to ensure appropriate breadth, depth and skill sets across the team to maintain and drive the business forward. Provides/solicits regular feedback from team and colleagues. Develops Technical/professional staff through coaching, assignment selection and associated training.

Importantly, the individual must:

• Provide strong leadership and demonstrate business acumen

• Demonstrate skill in project management and developing and leading high performing teams

• Proven record in change execution management, and strong analytical, communication and interpersonal skills and ability to drive accountability

• Collaborate with internal stakeholders and external partners as needed to achieve business goals

Education Minimum Requirement:

• Bachelor's Degree in Chemical Engineering, Biological Engineering, Mechanical Engineering, Chemistry, or related technical field

Required Experience and Skills:

• Minimum 10 years manufacturing or development experience in the areas of biologics, vaccine, or bulk sterile manufacturing facilities

• Technical expertise in the development or support of bulk biologics or vaccine processes

• Experience managing one or more direct reports

• Strong Understanding of Change Control

• Proven track record in leading cross-functional teams for delivery of complex projects

• Demonstrated skill in project management and developing and leading high performing teams

• Highly developed communication, leadership and teamwork skills and ability to drive accountability

• Ability to maintain strong working relationships with technical, quality and operations leaders in the internal and external network

Preferred Experience and Skills:

• Advanced degree (M.S., Ph.D.) in science or engineering

• Regulatory inspection presentation experience with external regulatory authority representatives.

• PMP certification

• Demonstrated leadership and capabilities in operational excellence and six sigma methods

• Manager of manager experience

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.

Invent. Impact. Inspire.

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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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R116687