Sr. Specialist, Engineering Job - United States
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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.
At the West Point facility in West Point, Pennsylvania, the Barrier Operations Technical Services team is seeking a highly motivated individual to partner with Manufacturing Operations, Quality Operations and Technical Services as an IPT Support Sr. Specialist. Tech Services provides technical engineering, process, automation, and validation support for the formulation and filling of Merck's liquid vaccines at West Point.
The Tech Services Sr. Specialist will be part of a cross functional team at our West Point, PA facility, charged with the technical support of the manufacturing shop floor in a multiproduct sterile form-fill vaccine facility. This role requires the ability to manage multiple projects and activities across the IPT. Strong communication and collaboration skills are essential. The successful candidate will also have robust problem solving skills and a hands-on approach to equipment and process issues, with a bias toward going to see problems for oneself in the field as they arise. Enthusiasm for continuous learning is a requirement.
- Lead complex manufacturing investigations for all aspects of Barrier Operations formulation and aseptic filling processes. Serve as a technical reviewer/approver for investigations and significant process changes.
- Provide technical support to manufacturing shop floor for in-process analytics, controls, and troubleshooting.
- Author and execute investigational and/or experimental protocols to generate data to support manufacturing routine or process validation/comparability activities. Ensure all technical writing meets requirements for manufacturing, compliance, and regulatory audiences.
- Manage end-to-end process improvement projects with the goal of improving right-first-time execution, reliability, and decreasing the cost of goods sold.
- Update technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstration, and validation.
- Link with key functional leads on site and above site to provide input on behalf of the site team.
- Take a leadership role in regulatory inspection activities for the facility through presentation of the team's work to multiple regulatory agencies throughout the life cycle of a process.
- Assist with troubleshooting and effectively resolving problems. Develop and implement corrective actions to unplanned (atypical) manufacturing events to ensure a consistent and reliable supply and prevent recurrence. The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, organization, and people) in order to best understand and resolve the root cause.
- Bachelor degree in an Engineering or Science Related field
- Six (6) years experience in GMP manufacturing and/or technical support of GMP manufacturing operations; four (4) years with a Masters Degree.
- Demonstrated a strong performance record and have excellent project management skills.
- Experience in sterile filling operations, biologics, vaccine or bulk sterile manufacturing facilities
- Highly developed communication, leadership and teamwork skills.
- Experience leading and managing departmental or cross-functional teams
- Regulatory inspection presentation experience with external regulatory authority representatives
- Strong understanding of process risk assessment tools, Quality by Design principles, and Lean/Six Sigma methodologies/certification
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 email@example.com.
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Visa sponsorship is not available for this position.
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Job: Chemical Engineering
Job Title:Sr. Spclst, Engineering
Primary Location: NA-US-PA-West Point
Employee Status: Regular
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Engineer, Lean Six Sigma, Supply, Compliance, Facilities, Engineering, Management, Operations, Legal