Merck Associate Director, Technical Operations in West Point, Pennsylvania
Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.
The Associate Director, Technical Operations, is responsible for the management and oversight of the technical support teams for the Varicella Bulk 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, collaboration with 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.
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.
- Applies management skills to align staff activities with department objectives.
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.
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.
Education Minimum Requirement :
- B.S. degree in Engineering or Sciences.
Required Experience and Skills:
Minimum 8-10 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.
Preferred Experience and Skills:
Advanced degree (M.S., PhD) in science or engineering.
Sterile manufacturing experience.
Six Sigma certification.
Regulatory inspection presentation experience with external regulatory authority representatives.
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
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
Invent. Impact. Inspire.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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.
No Travel Required
Flexible Work Arrangements:
1st - Day
Valid Driving License:
The responsibilities of this position require the employee to enter core sterile manufacturing areas.
Number of Openings:
Requisition ID: R123702
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