Associate Director, Engineering

Job Description

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 of the individual will be leading the technical team in their support of run the business activities that include 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. The Associate Director will have overall responsibility for the performance and results of the technical operations team supporting the IPT. 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 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.
• Responsible for building/growing the organization's functional excellence. Recruit and direct engineers and scientists as necessary. Develops technical/professional staff through mentoring, assignment selection and training.
• Manages team resources and prioritizes as aligned with business needs to include run the business support, project support, and continuous improvement activities - e.g. improve safety/compliance, reduce cost and increase 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 and engages 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.
• 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 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.
• Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
• Monitors the health of the process through continuous monitoring and the annual process review or continuing validation activities.
• Develops and assures consistent application of standardized work, engineering and process tools.
• Provides technical support to manufacturing for complex problems and issues.
• Coaches those providing technical support to manufacturing.
• Designs and conducts experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
• Authors and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
• Serve 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.
• Effectively collaborates with peers on site and above site as required.
• Expert application of problem-solving skills.

Impact:

Influence

• Explains difficult concepts and persuades others to adopt point of view.
• Communicates information, asks questions and checks for understanding.

Accountability

• Accountable for the performance of work group.

Decision Making

• Makes decisions - guided by policies, procedures and department objectives.
• Consults on an as-needed basis with next-level manager on more complex decisions.

Strategic Planning:

• Adapts and implements departmental plans and priorities based on department and site scorecard 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

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. 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 applicable 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:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our 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 be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is
$139,600.00 - $219,700.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ;br>
You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:
Regular

Relocation:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Required Skills:
API Manufacturing, Change Control Systems, Cross-Functional Teamwork, Equipment Qualification, Manufacturing Process Validation, People Leadership, Process Optimization, Regulatory Inspections, Regulatory Requirements, Strategic Thinking, Technical Guidance, Technology Transfer

Preferred Skills:

Job Posting End Date:
09/18/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.