Logo
MSD

Associate Director, Engineering

MSD, West Point, Nebraska, United States, 68788

Save Job

General Summary

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 directing production process performance, operations support, process validation, cleaning and sterilization validation activities, equipment/automation troubleshooting, implementing 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. General Profile

Builds talent by coaching and developing the Technical Operations team to ensure appropriate breadth, depth and skill sets, provides regular feedback, and develops technical/professional staff through coaching, assignment selection and training.

Responsible for building and growing the organization’s functional excellence; recruits and directs engineers and scientists as necessary; mentors staff through assignment selection and training.

Manages team resources and prioritizes work aligned with business needs, including run the business support, project support, and continuous improvement activities (e.g., safety/compliance, cost reduction, consistency and efficiency).

Provides leadership on schedule, priorities, and issue resolution to aid the team in accomplishing business objectives.

Adapts and implements departmental plans and priorities based on-site and End-to-End scorecard to address local business, service and operational challenges.

Collaborates with and engages multiple functional organizations to develop and maintain processes that meet cGMP and business requirements, including Operations, Technology, Quality, Automation, Global Engineering Services, Procurement, Finance, Above Site Technology, Regulatory, among others.

Provides technical guidance to staff, colleagues or customers; anticipates customer needs to identify solutions and approves technical documentation including investigations, protocols, qualification, validation, etc. as required. Responsible for presenting technical discussions to regulatory agencies during inspections.

Business Expertise

Applies management skills to align staff activities with department objectives.

Functional Expertise

Coaches, manages, and develops a team of engineers through a direct reporting relationship; recruits and hires engineers and scientists to support manufacturing operations.

Leads and/or coaches employees on complex manufacturing investigations and process improvement projects.

Examines issues from diverse perspectives (safety, compliance, automation, equipment, process, people) to identify root causes and resolutions.

Monitors process health through continuous monitoring and the annual process review or continuing validation activities.

Develops and applies standardized work, engineering and process tools consistently.

Provides technical support to manufacturing for complex problems and issues; coaches others providing technical support to manufacturing.

Designs and conducts experimental protocols as needed using Technical Operations lab facilities and/or production equipment at full scale.

Authors and updates technical and manufacturing documents for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.

Serves as a primary technical reviewer/approver for investigations and significant process changes.

Links with key functional leads on site and above site to provide input on behalf of the site team.

Takes a leadership role in regulatory inspection activities for the facility.

Problem Solving

Identifies and resolves technical and operational problems using lean/six sigma tools.

Collaborates effectively with peers on site and above site as required.

Applies advanced problem-solving skills.

Impact and Influence

Explains difficult concepts and persuades others to adopt a point of view; communicates information clearly and checks for understanding.

Accountability

Accountable for the performance of the work group.

Decision Making

Makes decisions guided by policies, procedures and department objectives; consults with next-level manager on more complex decisions as needed.

Strategic Planning

Adapts and implements departmental plans and priorities based on department and site scorecards to address local business, service and operational challenges.

Resource Management

Forecasts resource needs; manages allocated budget.

Education Minimum Requirement

B.S. degree in Engineering or Sciences.

Required Experience and Skills

Minimum 8 years post-bachelor’s degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or PhD degree plus 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.

Highly developed communication, leadership and teamwork skills.

Experience leading and managing departmental or cross-functional teams.

Preferred Experience and Skills

Advanced degree (M.S., PhD) in science or engineering.

Sterile manufacturing experience.

Validation experience.

Six Sigma certification.

Regulatory inspection presentation experience with external regulatory authority representatives.

Working Relationships

Reports to Technical Operations Director.

Manages employees within own department.

Interacts with employees within own department and from other departments.

Interacts with representatives from regulatory agencies.

Interacts with external suppliers.

Current employees apply here. Current contingent workers apply here. Regulatory and Employment Information

US and Puerto Rico Residents Only:

Our company is committed to inclusion. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the EEOC Know Your Rights and EEOC GINA Supplement pages. We are proud to be a company that embraces diverse experiences, perspectives, skills and backgrounds. We encourage colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts. U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will follow a Hybrid work model requiring three on-site days per week and a remote day on Friday, with specific site variations. This model does not apply to field-based roles, facility/manufacturing/research-based roles, roles under a collective-bargaining agreement, or roles where remote work is not reasonably possible. Compensation and Benefits The salary range for this role is $139,600.00 - $219,700.00. The successful candidate will be eligible for annual bonus and long-term incentives, if applicable. We offer a comprehensive benefits package, including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and sick days. More information is available at the compensation and benefits page. Application You can apply for this role through the Merck careers site. The application deadline is stated on this posting. Additional San Francisco residents: We will consider qualified applicants with arrest and conviction records in compliance with the San Francisco Fair Chance Ordinance. Los Angeles residents: We will consider all qualified applicants in accordance with local laws. Visa sponsorship: No. Travel requirements: 10%. Job Posting End Date 09/18/2025

#J-18808-Ljbffr