Engineering Strategic Projects Associate Director

The Engineering, Maintenance and Site Services (EMSS) organization continuously improve the reliability of the Durham Site operations and provides the best in class services with the final goal of delivering our high-quality vaccines to the patients around the world

With our core principle of Safety First and Quality Always EMSS strives to have the safest and most compliant operation around the network.

EMSS has an Associate Director opening for the Strategic Projects team. The selected candidate will manage the projects associated to Equipment, Site Utilities, and Facilities and will serve as the leader of a group of SME Engineers to support the Durham Site.

Strong technical and customer service-oriented leader to support the Durham Site. Will lead the tactical and strategic equipment reliability improvements and capital projects, human resources activities while ensuring a safe work environment with optimized product quality and manufacturing processes and regulatory compliance.

GENERAL PROFILE

• Provides leadership and direction through individual contributors

• Executes functional business plans and contributes to the development of group strategies

• Priorities based on compliance, departmental budget and profit plan to address resource and operational challenges

• Leverages relationships with key clients and/or customers to support business needs

PEOPLE MANAGEMENT

• Coaches/mentors direct reports responsible for their area

• Ensure proper team capabilities with appropriate training

• Manage the area succession plan

FINANCIAL MANAGEMENT

• Manage the assigned project budgets including capital spend, creating and managing all profit plans and forecasts throughout the year

PROJECT MANAGEMENT

• Responsible for major equipment or facilities related projects, including funding, change control and equipment qualification within their area

• Responsible for obtaining bids, reviewing contracts, supervising, and providing follows-up on contract work including the auditing of time and material reports for their area

• In collaboration with Maintenance and Reliability Engineering will be responsible for establishing the preventive maintenance, calibration programs and spare parts as a deliverable of each project

Responsible for the management of site’s low segment capital (<5MM) program to include:

• Will work with GES to ensure all projects >5MM meet their milestones.

• Oversee the forecasting and re-forecasting of all projects >1MM to ensure accuracy to the LRCP.

• Leads the sites Capital Review Meetings.

• Will work with GES and the Associate Director of Engineering Services to ensure status of current projects >1MM on the LRCP and placing new projects >1MM on the LRCP identifying time lines and milestones.

• QFD scoring and rating of all submitted capital projects <5MM.

• Tracking status of each project.

• Planning, forecasting and re-forecasting of the small capital plan.

• Work with IPT Leads and COE Leads to gain concurrence on all capital projects within their areas. Ensuring all funding documents are correctly completed.

• Oversight of the small capital team, ensuring costs are capitalized, projects scheduled and executed according to plan and project milestones met on time.

SHUTDOWN MANAGEMENT

• Responsible for assisting with master shutdown schedules and shutdown execution including all maintenance, calibration, capital project work, and GMP Cleaning coordination for all facility shutdowns

• Coordinates activities with stakeholders and project owners

• Attends shutdown meetings ensuring activities are tracked and completed

WORKING RELATIONSHIPS

• Reports to Engineering and Maintenance Director

• Manages and interacts with employees within own department

• Frequent interaction with employees from other departments

• Interacts with representatives from regulatory agencies

• Interacts with external suppliers

Education Minimum Requirement:

• Bachelor’s Degree in Engineering, Science or related technical field

Required Experience and Skills:

Minimum 8 years of progressive Project Engineering leadership experience in cGMP operations (6 Years with a master’s degree or MBA: 3 years with a PhD), or military service (US Navy, US Army, US Marine Corps, US Air Force, US Coast Guard) combined experience in the following functions:

• Project Engineering

• Maintenance Supervisor/Manager

• Reliability or Maintenance Engineering

• Utilities Maintenance and Operations

• Experience in introducing Reliability Engineering for Maintenance (RCM, FMEA, Criticality Analysis, PM optimization, RCA, etc.)

• Strong planning, scheduling, and time management skills

• Working knowledge regulatory requirements in accordance with cGMP manufacturing operations and demonstrated experience of interacting with site, divisional or regulatory audits/inspections.

• Good oral and written communication skills

• Project management, including change control and equipment qualification

Preferred Experience and Skills:

• 15 years of Maintenance and Military experience in a GMP regulated industry in the Maintenance or Engineering field.

• SAP experience related to plant maintenance and spare parts procurement systems

• Experience running a Project Engineering program.

• At least seven years of experience in military service (US Navy, US Army, US Marine Corps, US Air Force, US Coast Guard)

• Working Knowledge of cGMP for pharmaceutical, Sterile and/or Biologics manufacturing

​ Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals 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 …

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.

Direct link: https://jobs.merck.com/us/en/job/R158144/Engineering-Strategic-Projects-Associate-Director