Associate Director, Engineering
Merck
**Job Description**
The Associate Director – Purification Technology Lead within the Vaccine Technical Operations organization will be responsible for tactical and strategic decisions related to tech transfer and process stabilization. The Associate Director will ensure optimized product quality and manufacturing processes, regulatory compliance, employee and environmental safety, integration of new/existing technologies, customer service, resource utilization, financial performance and fiscal stewardship.
The role encompasses purification area (Purification suites 4 and 5) support for technical/process issues, strategic projects, deviation management, change management, quality risk management, licensure and filing project management, and human resource activities for a technical staff.
**GENERAL PROFILE**
+ Provides leadership and direction for a team of individual contributor full-time employees
+ Adheres to site/project priorities based on departmental budget and profit plan to address resource and operational challenges
+ Is part of the Facility Technical Operations Leadership Team along with partners from other suite teams
+ Also interacts with other functional groups, including Operations, Quality, Automation, Maintenance and Safety
**PEOPLE MANAGEMENT**
+ Coaches/mentors direct reports responsible for their area within Technical Operations
+ Executes tasks related to people development such as one-on-ones, mid-year reviews, year-end review/calibration, team staff meetings, new employee onboarding, etc
**FINANCIAL MANAGEMENT**
+ Assists Technical Director with managing the Technical cost center, including capital spend, creating and managing all profit plans and forecasts throughout the year related to hiring and schedule adherence
**TECHNICAL SUPPORT**
+ Responsible for execution of deviation management activities, including coaching staff through incident/investigation authoring, QN review/approval, speaking to QNs pulled for audits/inspections
+ Responsible for oversight and project management of regulatory filing preparedness in the Purification area – including interactions with CMC-Reg, providing source documents, escalating needs and issues related to license readiness
+ Responsible for technology transfer and qualification of the purification process, including successful completion of engineering runs, clinical batches, successful process validation, and maintaining alignment with the sending/partner sites in the network
+ Collaborates with internal/external partners, e.g. Other company sites, CMC-Reg, Procurement, Planning, Quality CoE, etc
+ Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments
+ Leads aspects of regulatory inspections by presenting and defending technical documentation, investigations, and change controls
+ Evaluates and develops innovative process technologies, continuous process improvements and post launch process enhancements
+ Provides post approval support and subject matter expertise support to ongoing manufacturing activities.
+ Develops a team of competent technical professionals through one-on-ones, midyear reviews, year-end reviews and continuous improvement efforts
**QUALIFICATIONS**
**Essential:**
+ Bachelors Degree in Engineering, Science or related field
+ Minimum 8 years of experience in a GMP Facility or Capital Project as a technical staff member
+ Previous people management experience required, including contractor management
+ Strong planning, scheduling, and time management skills
+ Working knowledge of regulatory requirements in accordance with GMP manufacturing operations
+ Good oral and written communication skills
+ Experience with tech transfer activities and regulatory inspections
+ Experience with deviation management and change control
+ Project management, including change control, validation and equipment qualification
+ Experience with tangential flow filtration and chromatography unit operations is preferred
**WORKING RELATIONSHIPS**
+ Reports to Director, Technical Operations
+ 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
**Note:**
This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
**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 (https://survey.sogosurvey.com/r/aCdfqL) 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:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf)
EEOC GINA Supplement
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 (https://www.msdprivacy.com/us/en/CCPA-notice/)
**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”.
**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:**
Not Applicable
**Shift:**
1st - Day
**Valid Driving License:**
No
**Hazardous Material(s):**
n/a
**Job Posting End Date:**
05/14/2025
***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.**
**Requisition ID:** R347578
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