Merck Senior Specialist, Engineering - Validation in Durham, North Carolina
Our Engineers support internal and external manufacturing operations to remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biologics, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.
Our Company is expanding its global vaccine production network for Vaccine Manufacturing in Durham, NC. The new facility will be used to produce the bulk active ingredient for the Human Papilloma Virus (HPV) vaccine, comprised of sterile supply, fermentation, microfiltration/ultrafiltration, chromatography, and adjuvant production steps. Approximately 614,000 people are diagnosed with certain Human Papilloma Virus -related cancers each year.
Our Company manufactures vaccines that are predominantly utilized to eradicate these cancers globally. In recent years, countries around the world have enacted new or expanded Human Papilloma Virus vaccination programs, which has created an unprecedented increase in global demand. The manufacturing facility in Durham will play a critical role in the network of plants that produce life-saving medicines and vaccines, including our Human Papilloma Virus vaccines.
The successful candidate will be energetic and technically sound, with strong interpersonal, communication, and collaboration skills responsible for supporting FAT, IQ and OQ while specifically providing cycle development and Process Qualification (PQ) for equipment and systems supporting bulk biological processes (i.e. Sterile Supply, Adjuvant Manufacturing, Fermentation, and Purification). This is position will primarily support vaccine drug substance site readiness via Validation program implementation, partnering with cross-functional teams (i.e. Maintenance, Global Engineering, Quality, and Operations} to ensure a successful technology transfer, filing, and licensure for a new Human Papilloma Virus vaccine drug substance manufacturing facility.
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 at times based on business unit needs and specific assignments.
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 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 the associated documentation
Participate in the equipment specification, selection/procurement, and qualification phases of vaccine capital projects
Collaborate with internal/external partners, e.g. Other Company 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 in 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 Operation's team members to develop reliable, consistent manufacturing processes that meet current Good Manufacturing Practices (cGMP)requirements.
Provide documented evidence that processes are consistent and reliable through challenges against pre-established criteria.
May be responsible for leading teams of contractors to efficiently accomplish project goals.
Provide technical support to help develop and execute project plans; and obtain and analyze relevant data and prepare appropriate reports for regulatory submissions.
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 mentor for less experienced teammates, assisting with technical development.
Author or update Validation SOPs
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 with a minimum of five (5) years of relevant experience;
or a Master of Science Degree with a minimum of three (3) years of relevant experience;
or a Ph.D. with relevant academic experience.
Required Experience and Skills:
Experience in vaccine or biologics manufacturing within a current Good Manufacturing Practices (cGMP) environment
Experience authoring technical documentation within a current Good Manufacturing Practices (cGMP) context
Outstanding communication (written & presentation) skills
Experience with project strategic plan development and management
Preferred Experience and Skills:
Experience in bulk upstream and/or downstream vaccine processes within a current Good Manufacturing Practices (cGMP) environment
Experience with facility, equipment, and process start-up in a sterile current Good Manufacturing Practices (GMP) environment.
Sanitization and Sterilization validation (SIP, autoclaves, depyrogenation ovens, VHP)
Cleaning validation (CIP, COP)
Validation experience in support of Good Manufacturing Practices 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
Strong technical problem-solving abilities
Familiarity with regulatory requirements
Demonstrated effective written and verbal communication skills
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
The ability to work well under pressure and achieve results within tight deadlines
Travel : Up to 20% of the time
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
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Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
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Requisition ID: R38555
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