Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Associate Director, Technical Operations is responsible for the oversight of one of the technical sub-teams within the technical organization at the West Point site. In this role the Associate Director will guide a team of individual contributors in tasks that may include executing and directing production process performance, process validation and technical transfer, sterilization and cleaning validation, change implementation, deviation investigations and/or CAPA implementation among other related duties.
Leads the vision inspection group at WP. The group is responsible for all technical knowledge of the product inspection equipment for in-line sterile products in syringes, vials, or sealed tubes. Provides support to investigations and changes of primary components, and product changes solution/suspensions/lyophilized cakes.
- Manages individual contributors (professional employees)
- Contributes to the performance and results of a department.
- Provides technical guidance.
- Anticipates and interprets client and/or customer needs to identify solutions.
- Applies management skills to align staff activities with department objectives.
- Provides process, equipment, and operational knowledge in design of new inspection equipment and new inspection technology.
- Responsible for characterizing the process parameter ranges for products on the inspection equipment.
- Lead role in inspection equipment design, selection, FAT, IQ/OQ, and PQ including role as CPTL for new inspection machine projects
- Serves as a vision inspection subject matter expert within Merck, externally, and during regulatory inspections
- Critical leader in ensuring all validation work is completed according to plan.
- Responsible for establishing statistical process control limits for inspection process reject rates
- 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.
- 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.
- Explains difficult concepts and persuades others to adopt point of view.
- Communicates information, asks questions and checks for understanding.
- 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.
- Adapts and implements departmental plans and priorities based on department and site scorecard to address local business, service and operational challenges.
- Forecasts resource needs; manages allocated budget.
- 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
- B.S. degree in Engineering or Sciences.
- Minimum 8 years post-bachelor's degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree plus 8 years; 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.
- Some travel required (<5>
- BS, MS or PhD in Chemical, Mechanical, or Electrical Engineering
- Vision inspection systems experience, validation or automation focus, tendency to work hands on
- Has a practical understanding and application of technical guidance documents e.g. PDA technical reports.
- Experience in vaccine or sterile product manufacturing
- Strong technical writing and communication skills, strong project management skills
- Advanced degree (M.S., PhD) in science or engineering.
- Sterile manufacturing and/or Vaccine manufacturing experience.
- Validation experience
- Six Sigma certification.
- Regulatory inspection presentation experience with external regulatory authority representatives.
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Visa sponsorship is not available for this position.
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