Merck Associate Director, Engineering Quality Assurance, Global Engineering Solutions in West Point, Pennsylvania
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Associate Director functions under the guidance of the Associate Director, Engineering Quality Assurance, within Global Engineering Solutions (GES) with focus on providing design and execution expertise to ensure that our designs are safe, reliable and fit for purpose and that they can be properly transferred to the field. The Associate Director will help to minimize compliance issues by collaborating with engineering design and execution teams, facilitating the review of design data and identifying and resolving product and engineering design issues prior to starting construction. In addition, the role will help ensure robust procedures are in place to ensure that our designs are accurately translated to the field, right-first-time. This role will bridge the gap between design and delivery to help ensure that our designs are complete and that they are properly constructed.
The Associate Director exhibits strong leadership, interpersonal and communication skills, decision making and the ability to guide global work. The candidate should have a strong understanding of equipment and facility design, safety practices, standards, operations, maintenance and industry regulations. Flexibility with global travel and varied work location is also required.
The Associate Director will contribute to the development and maintenance of core documents such as internal practices, procedures, design guides and engineering standards. In addition, they should participate in professional/technical organizations and in the development and delivery of subject matter training for GES.
Primary responsibilities include, but are not limited to:
Serve as a champion of Engineering Design Quality by utilizing either an engineering firm background or pharmaceutical quality background (with focus on execution).
Manage the peer review process on multiple projects as the Engineering QA representative, working with Project Teams and EPCM partners to ensure appropriate reviews are conducted, including Merck SME reviews and/or independent 3rd party reviews.
Assist in the improvement of the Peer Review process to ensure internal/external requirements are fully addressed in project design and execution.
Support Business Integrators in identifying applicable requirements and risks during project initiation and concept development.
Interface with Technology Center Design Engineering Solutions group to incorporate appropriate SMEs into Peer Review process.
Participate/lead root cause investigations on project compliance issues and, based on lessons learned, identify and implement process changes needed to prevent recurrance.
Coordinate Project Assessments for recently completed projects.
Lead & coordinate resources for project readiness assessments on current projects.
Education Minimum Requirement : BS Degree in Chemical or Mechanical Engineering or an equivalent degree
Required Experience and Skills:
The Associate Director must exhibit strong interpersonal and communication skills, decision making and the ability to guide global work. The candidate should have a strong understanding of equipment and facility design, safety practices, standards, operations, maintenance and industry regulations.
Project Execution Experience, including leadership roles on capital projects in the Pharmaceutical/ Biotech or Chemical Industry
Ability and experience to implement a design engineering quality program related to capital project execution
Excellent analytical abilities and a solid base in engineering fundamentals
Demonstrated leadership, teamwork and interpersonal skills
Proven written and verbal communication skills – English – as the platform language for communication in science and engineering
Ability to foster strong collaborative working relationships with internal colleagues and customers, and external partner resources in a culturally diverse environment
Teaching, training and coaching of internal colleagues and partner resources
Dynamic ability to work across a portfolio of projects; prior project management knowledge preferred
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Visa sponsorship is not available for this position.
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Job Chemical Engineering
Other Locations: NA-US-NC-Durham-RTP, NA-US-NJ-Kenilworth
Title: Associate Director, Engineering Quality Assurance, Global Engineering Solutions
Primary Location: NA-US-PA-West Point
Requisition ID: CHE006327