This job opportunity is no longer available.
This page has been archived for your
reference. You can try to continue to this position on the employer's website
or try a new search. Inquiries related
to this position should be directed to the employer.
Description
Design, Demonstration and Start-Up Vaccine Facility Process Engineer-CHE002580
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 Viral Vaccine Technology & Engineering (VVTE) Center of Excellence is seeking a highly motivated individual to partner with Manufacturing Operations, Quality Operations and Process Automation as a member of the demonstration team for the new Durham Vaccine Bulk Facility. VVTE provides technical and validation support for the manufacture of Merck's cell-culture based vaccines at Durham, with the team initially focused on the demonstration of a new bulk facility supporting VARIVAX (Chicken Pox Vaccine) and ZOSTAVAX (Shingles vaccine) manufacturing.
The Process Engineer will be part of a team at our Durham, NC, site charged with expanding the existing bulk manufacturing facility capacity by at least 50%. This assignment will require close partnership and collaboration with Global Engineering Services and Manufacturing Operations to ensure that process design requirements are fully understood and evaluated, and that the expansion is seamlessly integrated into the existing bulk production facility. This individual will be integrated in the design/construction team from the beginning of the project and will transition to a lead role in the demonstration and startup of the process over time. At times the Process Engineer will be required to formally or informally coach a group of employees on work assignments associated with the capacity expansion project as well as employee development.
This type of support typically requires the ability to manage multiple projects and activities across the project. Strong communication and collaboration skills are essential. The successful candidate will also have strong 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.
The individual must embrace and be committed to establishing an empowered team culture, with the goal of each employee reaching their fullest potential and having accountability, authority and responsibility to one another, our community and our patients.
Primary Activities:
1. Lead the operational and process definition input into the facility expansion project team. Link with key functional leads on site to provide input on behalf of the site team. 2. Develop technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstration, and validation. 3. Serve as a mentor for less experienced employees in the team, assisting them in their technical and professional development. 4. Participate in the facility expansion design, qualification, startup and process demonstration activities. Serve a lead role in the qualification through process validation activities, working alongside operations team members to develop reliable, consistent manufacturing processes that meet our cGMP requirements. 5. Assist in authoring the regulatory submission for the facility and present your work to multiple regulatory agencies throughout the pre-approval inspection processes. 6. 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 it at root cause. 7. Initial travel to vendors and to the Merck site at West Point to ensure successful start-up. Note that limited off-shift or weekend coverage may be required based on project-specific assignments.
Qualifications /B
Required:
* B.S. in chemical engineering, the biological sciences or related discipline with solid academic record and/or relevant work experience. * Minimum 6 years post-bachelors degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations; Minimum 4 years with a Masters Degree. * Experience in biologics, vaccine or bulk sterile manufacturing facilities * Highly developed communication, leadership and teamwork skills. * Experience leading and managing departmental or cross-functional teams * Experience with new facility construction and qualification activities
Preferred:
* M.S. in chemical engineering, the biological sciences or related discipline with solid academic record and/or relevant work experience. * Black Belt Certification * Previous cell culture and open aseptic processing experience * Regulatory inspection presentation experience with external regulatory authority representatives
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. Merck'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.
merckmanufacturing-durham.com/ to create a profile and your resume for requisition # CHE002580. Merck is an equal opportunity employer, M/F/D/V - proudly embracing diversity in all of its manifestations.
Search Firm Representatives
Please Read Carefully:
Merck 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.
Primary Location :US-NC-Durham
Employee Status :Regular
Number of Openings :1
Shift (if applicable) :N/A
Details:
Job Id:
894900A0
Posted / Updated:
9/1/2010 4:01:38 AM
Map
Careers & Community for Talented People with Disabilities