Process Validation Engineer Job - United States
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.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
As part of Merck's Global Vaccine Technology organization (GVT), the Process Validation team within the Organon Teknika (BCG) vaccine manufacturing facility in Durham, NC is seeking a Process Validation Engineer. The Process Validation team provides technical process and validation support for the manufacture of Merck's BCG culture based product. The Process Validation Engineer will partner with Manufacturing Operations, Quality Control, Plant Engineering, Automation, Technology, and Global Engineering Services as a member of the Process Validation Team supporting the Durham BCG Independent Process Team (IPT).
The scope of activities for this position includes, but is not limited to: process development, process optimization, and equipment validation/qualification activities (commissioning, IQ, OQ, PQ) associated with the following processes:
- Sterilization (SIP, Autoclaves, Depyrogenation, chemical decontamination)
- Cleaning (CIP, COP, parts washers)
- Controlled Temperature Units (incubators, freezers, refrigerators)
- Aseptic processing
- Developmental equipment, testing, or process studies
- Process/Equipment Change Management
The successful candidate will be a self-starter, with strong analytical problem solving skills, enjoys hands-on approach for project management, with well-established technical writing skills. The successful candidate should be able to examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand root cause, and implement preventive actions.
- Lead the development and execution of process and or equipment validation studies to define or establish critical process parameters.
- Author technical documents such as protocols, feasibility studies, change controls and deviation investigations that align with corporate standards and industry requirements.
- Support, participate, and lead process improvement projects in support of Site goals and objectives.
- Author and adhere to Change Control procedures and ensure processes are maintained in a validated state through recertification / re-validation activities.
- Support regulatory filing submissions for equipment and processes as needed.
- Provide technical and/or investigational support in troubleshooting and resolving manufacturing process issues.
- Develop and implement effective corrective and/or preventive actions to (atypical) manufacturing events to ensure a consistent and reliable supply and prevent recurrence.
- Participate on multiple project teams to develop local site systems or achieve site goals/objectives.
- Partner (collaborate) with other internal departments (Operations, Quality, Plant Engineering, and Technology), and external centers of excellence (COEs) on process or validation related activities/events.
Education Minimum Requirement:
B.S. (or equivalent 4-year degree) in Engineering or Science
Required Experience and Skills:
- Minimum of 2 years’ experience in GMP Manufacturing / Technical Engineering Support Role
- Experience preparing/authoring technical documentation / validation protocols.
- Effective communication - both verbal and written
- Demonstrated collaboration and teamwork skills
- Demonstrate project management skills
Preferred Experience and Skills:
- 4 or more years validation experience with cross-functional, project based teams
- Previous experience with sterilizers, controlled temperature units, plant utility systems, cleaning validation, and/or process development.
- Lean Six Sigma (LSS) training or certifications.
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.
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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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Job: Process Engineering
Job Title:Spclst, Engineering
Primary Location: NA-US-NC-Durham
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: Yes
Company Trade Name:Merck
Nearest Major Market: Durham
Nearest Secondary Market: Raleigh
Job Segment: Developer, Process Engineer, Manufacturing Engineer, Engineer, Lean Six Sigma, Technology, Engineering, Management