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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.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.
The Validation Senior Specialist will be an energetic, technical leader with strong interpersonal, communication, and collaboration skills responsible for supporting FAT, IQ and OQ while specifically providing cycle development and PQ for equipment and systems supporting bulk biological processes including purification and fermentation, including vaccine and sterile manufacturing. This is position will primarily support vaccine drug substance site readiness via validation program implementation.
Additionally, this role will contribute to the performance and results of a department, provide validation guidance, and anticipate and interpret client and/or customer needs to identify and implement solutions. Off-shift and weekend coverage will be required based on business unit needs and specific assignments.
The role encompasses validation support associated with the development of new products, processes, systems, utilities, and facilities in support of new products; mainly supporting cleaning, sanitization, depyrogenation and sterilization validation (CIP, COP, dry heat ovens, SIP and Autoclave load patterns). Specific assignments may be focused in one area or span across multiple areas of focus.
Responsibilities may include but are not limited to;
- Provide validation support and leadership for commercial technology transfer, and qualification studies associated with the development and implementation of processes, systems and facilities related to vaccine drug substance and key intermediates e.g. buffers, media and cleaning solutions.
- Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process
- Lead validation studies and author documentation associated with site commercialization efforts
- Participate in the equipment specification, selection/procurement, and qualification phases of vaccine capital projects
- Collaborate with internal/external partners, e.g. Other Merck sites, Procurement, Raw Material & Component Suppliers
- Author, review, and/or edit validation documents to support regulatory filings
- Support Change Control documentation for complex process, validation, analytical, equipment, facility/utility and/or automation changes.
- Lead validation topics of regulatory inspections by presenting and defending validation documentation.
- Develop technical and manufacturing documents necessary for development studies, cleaning, sanitization, depyrogenation and sterilization process validation.
- Participate in the feasibility activities working alongside operations team members to develop reliable, consistent manufacturing processes that meet cGMP requirements.
- Provide documented evidence that processes are consistent and reliable through challenges against pre-established criteria.
- Provide technical support to help develop and execute project plans; and obtain and analyze relevant data and prepare appropriate reports for regulatory submissions.
- May be responsible for leading teams of contractors to efficiently accomplish project goals.
- Provide contributions to the planning, design, and implementation of segments of new facilities, systems and equipment in a cost effective and timely manner.
- Design validation studies, author and approve protocols, and ensure alignment with corporate standards and site guidance for validation.
- Serve as a mentor for less experienced employees in the Validation team, assisting them in their technical development.
- Assist in authoring the regulatory submission for the facility and present your work to multiple regulatory agencies throughout the pre-approval inspection processes.
- 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) to best understand and resolve it at root cause.
- Maintain alignment with internal technical personnel regarding validation practices for products, processes and equipment.
- Partner with Operations, Quality, and Automation functional areas on validation study implementation
Education Minimum Requirement:
- Bachelor of Science Degree in Engineering or Life Sciences
Required Experience and Skills:
- Five (5) years of relevant experience; a Master of Science Degree with three (3) years of relevant experience; or a Ph.D. with relevant academic experience.
- Experience in vaccine or biologics manufacturing within a cGMP environment
- Experience authoring technical documentation within a cGMP context
- Proven leader with influence and outstanding communication (written & presentation) skills
- Experience with project strategic plan development and management
- Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development
Preferred Experience and Skills:
- Experience in bulk upstream and/or downstream vaccine processes within a cGMP environment
- Ability to read Piping and Instrumentation Diagrams is desired
- Experience with responding to regulatory questions with multiple agencies (e.g.FDA, EMA)
- Experience with face to face presentation of technically complex subjects to regulatory inspectors
- Experience with facility, equipment and process start-up in a sterile GMP environment.
- Sanitization and Sterilization validation (SIP, autoclaves, depyrogenation ovens)
- Cleaning validation (CIP, COP)
- Validation experience in support of GMP process demonstration (IQ/OQ/PQ)
- Sustaining the validated state through change management and continuing validation studies
- Demonstrated ability to work both independently and as a part of a team
- Experience leading small groups in a GMP environment
- Familiarity with regulatory requirements
- Strong technical problem-solving abilities
- Demonstrated effective written and verbal communication skills; ability to influence both peers and management in building consensus
- Strong collaboration and leadership skills
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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