Merck
Overview
Join to apply for the
Associate Director, Engineering
role at
Merck . The Associate Director, Technical Operations, is responsible for the management and oversight of the technical support teams for the MMR Bulk team within the Live Viral Vaccine End-to-End, at the West Point site. The primary responsibility is leading the technical team in supporting run the business activities, including executing and directing production process performance, operations support, process validation, cleaning and sterilization validation activities, equipment/automation troubleshooting, implementation of process/equipment/analytical changes, oversight of the deviation management team and installation of robust CAPAs, among other related duties. Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments.
Responsibilities
Builds talent by coaching and developing Technical Operations team members to ensure breadth, depth and skill sets; provides/solicits regular feedback; develops staff through coaching, assignments and training.
Builds and grows the organization’s functional excellence; recruits and directs engineers and scientists; mentors and trains staff.
Manages team resources and prioritizes run-the-business support, project support, and continuous improvement activities (safety/compliance, cost reduction, consistency and efficiency).
Provides leadership on schedule, priorities and issue resolution to achieve business objectives.
Adapts and implements department plans and priorities based on site and End-to-End scorecards to address local business, service and operational challenges.
Collaborates with Operations, Technology, Quality, Automation, Global Engineering Services, Procurement, Finance, Above Site Technology, Regulatory, and others to develop and maintain processes that meet cGMP and business requirements.
Provides technical guidance to staff and customers; approves technical documentation (investigations, protocols, qualifications, validation); presents technical discussions to regulatory agencies during inspections.
Qualifications
Education:
B.S. in Engineering or Sciences.
Experience:
Minimum 8 years post-bachelor’s degree in GMP manufacturing and/or technical support of GMP manufacturing operations (or PhD + 6 years); minimum two years of management or supervisory experience; experience in biologics, vaccine or bulk sterile manufacturing facilities in a process or validation support role; strong communication, leadership and teamwork skills; experience leading cross-functional teams.
Skills:
Highly developed communication, leadership and teamwork; ability to examine issues from multiple perspectives (safety, compliance, automation, equipment, process, people); monitor process health; develop standardized work and process tools; provide technical support for complex problems; guide investigations and change control; regulatory inspection readiness.
Preferred Experience and Skills
Advanced degree (M.S., PhD) in science or engineering.
Sterile manufacturing experience.
Validation experience; Six Sigma certification; regulatory inspection experience.
Working Relationships
Reports to Technical Operations Director.
Manages employees within own department; interacts with other departments and regulatory agencies; interacts with external suppliers.
Additional Details
US and Puerto Rico residents only; hybrid work model in the U.S. with three days on-site per week (Mon–Thu) and Friday remote, with exceptions for certain roles.
Salary range:
$139,600.00 - $219,700.00 .
Full-time employment; relocation (domestic); no visa sponsorship; travel requirements ~10%.
Application information and benefits details are available on Merck’s careers site.
Relevant legal and equal opportunity statements are retained as part of standard postings.
#J-18808-Ljbffr
Join to apply for the
Associate Director, Engineering
role at
Merck . The Associate Director, Technical Operations, is responsible for the management and oversight of the technical support teams for the MMR Bulk team within the Live Viral Vaccine End-to-End, at the West Point site. The primary responsibility is leading the technical team in supporting run the business activities, including executing and directing production process performance, operations support, process validation, cleaning and sterilization validation activities, equipment/automation troubleshooting, implementation of process/equipment/analytical changes, oversight of the deviation management team and installation of robust CAPAs, among other related duties. Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments.
Responsibilities
Builds talent by coaching and developing Technical Operations team members to ensure breadth, depth and skill sets; provides/solicits regular feedback; develops staff through coaching, assignments and training.
Builds and grows the organization’s functional excellence; recruits and directs engineers and scientists; mentors and trains staff.
Manages team resources and prioritizes run-the-business support, project support, and continuous improvement activities (safety/compliance, cost reduction, consistency and efficiency).
Provides leadership on schedule, priorities and issue resolution to achieve business objectives.
Adapts and implements department plans and priorities based on site and End-to-End scorecards to address local business, service and operational challenges.
Collaborates with Operations, Technology, Quality, Automation, Global Engineering Services, Procurement, Finance, Above Site Technology, Regulatory, and others to develop and maintain processes that meet cGMP and business requirements.
Provides technical guidance to staff and customers; approves technical documentation (investigations, protocols, qualifications, validation); presents technical discussions to regulatory agencies during inspections.
Qualifications
Education:
B.S. in Engineering or Sciences.
Experience:
Minimum 8 years post-bachelor’s degree in GMP manufacturing and/or technical support of GMP manufacturing operations (or PhD + 6 years); minimum two years of management or supervisory experience; experience in biologics, vaccine or bulk sterile manufacturing facilities in a process or validation support role; strong communication, leadership and teamwork skills; experience leading cross-functional teams.
Skills:
Highly developed communication, leadership and teamwork; ability to examine issues from multiple perspectives (safety, compliance, automation, equipment, process, people); monitor process health; develop standardized work and process tools; provide technical support for complex problems; guide investigations and change control; regulatory inspection readiness.
Preferred Experience and Skills
Advanced degree (M.S., PhD) in science or engineering.
Sterile manufacturing experience.
Validation experience; Six Sigma certification; regulatory inspection experience.
Working Relationships
Reports to Technical Operations Director.
Manages employees within own department; interacts with other departments and regulatory agencies; interacts with external suppliers.
Additional Details
US and Puerto Rico residents only; hybrid work model in the U.S. with three days on-site per week (Mon–Thu) and Friday remote, with exceptions for certain roles.
Salary range:
$139,600.00 - $219,700.00 .
Full-time employment; relocation (domestic); no visa sponsorship; travel requirements ~10%.
Application information and benefits details are available on Merck’s careers site.
Relevant legal and equal opportunity statements are retained as part of standard postings.
#J-18808-Ljbffr