Sr. Specialist, IPT Support Engineer Vaccine Operations Job

Sr. Specialist, IPT Support Engineer Vaccine Operations-CHE005203

Description

Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as 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 people 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 Durham Vaccine Facility in Durham, North Carolina, the Global Vaccine Technology & Engineering (GVTE) team is seeking a highly motivated individual to partner with Manufacturing Operations, Quality Operations and Process Automation as an IPT Support Sr. Specialist. GVTE provides technical engineering and validation support for the manufacture of Merck's live virus vaccines at Durham.

The IPT (Integrated Process Team) Support Sr. Specialist will be part of a cross functional team at our Durham, NC facility, charged with the technical support of the manufacturing shop floor in sterile fill-finish 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 validation and problem solving, with a bias toward going to see problems for oneself in the field as they arise. Enthusiasm for continuously learning is a requirement.

Primary Activities:
• Lead complex manufacturing investigations for the equipment preparation, media preparation, and Stabilizer Formulation areas of the aseptic manufacturing process. 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.
• Conduct experimental protocols as needed using the Technical Operations lab (investigational and development lab).
• Manage end-to-end process improvement projects with the goal of improving right-first-time execution 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, and people) in order to best understand and resolve the root cause.

Qualifications

Education Minimum Requirement:

•Bachelor degree in an Engineering or Science Related field
•Minimum 6 years experience in GMP manufacturing and/or technical support of GMP manufacturing operations; Minimum 4 years with a Masters Degree.

Required Experience and Skills:

•Demonstrated a strong performance record and have excellent project management skills.
•Experience in biologics, vaccine or bulk sterile manufacturing facilities
•Experience in Sterile Filling Operations
•Highly developed communication, leadership and teamwork skills.

Preferred Experience and 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 staffingaadar@merck.com.

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.

For more information about personal rights under Equal Employment Opportunity, visit:

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Chemical Engineering

Job Title:Sr. Spclst, Engineering

Primary Location: NA-US-NC-Durham

Employee Status: Regular

Travel: Yes, 5 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Hazardous Materials: No

Company Trade Name:Merck