Associate Director, Engineering
Associate Director, Engineering
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
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 fulltime 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 oneonones midyear reviews yearend 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 CMCReg 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 CMCReg 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 oneonones midyear reviews yearend 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 allinclusive 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
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 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:
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 anothers 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 officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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 preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
1st DayValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
05/14/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Director
Employment Type
Full-Time
