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 Sr. Specialist, Technical Services Process Engineering in the BioBacterial Manufacturing End-to-End is responsible for technical leadership and execution of projects in the commercial manufacturing area while actively supporting, participating in, and embracing an empowered team culture. In this role, the Sr. Specialist will work as an individual contributor as well as a team or project lead to lead work of others as required. Additionally, this role will contribute to the performance and results of a department, provides technical guidance, and anticipate and interpret client and/or customer needs to identify and implement solutions. Additional responsibilities include:
- Establish and manage project schedules and timelines.
- Determine project resource requirements and works with stakeholders to gain support needed from subject matter experts. Stakeholders may include Operations, Quality, Regulatory, Analytical and Process Development functions.
- Lead and execute process improvement projects and complex manufacturing investigations.
- Responsible for stakeholder engagement, communication, and risk escalation.
- Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.
- Author and update technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstrations, and validation.
- Design and conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
- Coach, manage, and develop a team of engineers through an indirect reporting relationship.
- Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
- Develop and assures consistent application of standardized work, engineering, and process tools.
- Provide technical support to manufacturing for complex problems and issues.
- Lead and/or work as a team member on complete manufacturing investigations, process improvement and/or validation projects.
- May serve as a technical reviewer/approver for investigations and process changes.
- Participate in regulatory inspection activities for the facility
- Bachelor's Degree in Engineering or Science
- Minimum 6 years post-bachelor's degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree plus 4 years; PhD degree plus 2 years).
- Experience in biologics, vaccine ,or bulk sterile manufacturing facilities in a process or validation support role
- Advanced degree (M.S., Ph.D.) in science or engineering
- Experience in biologics, vaccine, or bulk sterile manufacturing facilities.
- Regulatory inspection presentation experience with external regulatory authority representatives.
- PMP certification
- Strong Understanding of Change Control
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org. Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
Visa sponsorship is not available for this position.
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