Master Data Specialist, Engineering (Onsite)
About The Position
Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology, we collaborate to discover the next medical breakthrough. Applications are sought for an SAP Master Data Specialist in Vaccines and Advanced Biotechnologies Process R&D (VAX PR&D). The role supports pilot-scale GMP manufacture of bulk biologic clinical supplies (vaccines and therapeutic proteins) and will create, design, and sustain standardized business processes, master data management, system sustainment, and lifecycle material management, while providing support for peer coaching and consultation as needed. The position will be temporarily based in West Point, PA for approximately 18 months (up to 24 months) to support business needs. After this period, the role is intended to relocate to Rahway, NJ. Applicants should be comfortable with this planned geographic transition. This role will be part of the VAX PR&D Planning and Manufacturing Systems (PAMS) team before transitioning to support the Next Generation Biologics (NGB) facility— a forthcoming state-of-the-art, multi-product GMP site at the CMC hub in Rahway, NJ. NGB will enable flexible multi-suite operations across development and pilot scales, support potent-material handling, and integrate novel cell-line and technology platforms. The Biologics Process R&D organization develops drug-substance manufacturing processes across biotherapeutic modalities and partners with Discovery, Pre-clinical, Early Development, and Manufacturing to enable clinical supply and commercial launches, including implementation of new technologies and scalable processes. The SAP Master Data Specialist will use SAP, business process knowledge, and SOPs to maintain alignment with global business processes and site regulatory requirements. The successful candidate will work closely with Process Staff, Formulators, Engineers, IT, Quality, and other team members to understand and execute master data requirements, support cross-functional initiatives, and contribute to continuous improvement.
Requirements
- BS degree in Engineering, Sciences, Business, or a related field with minimum 2 full years of relevant experience or a Master’s degree with 1+ year of relevant experience
- Direct experience with working with SAP master data
- Strong understanding of manufacturing principles/processes through work experience and ability to translate manufacturing requirements into an Automation/Digital Solution
- Ability to work collaboratively as part of a team across various functions in a challenging and changing global environment
- Proven track record of analytical skills, problem solving, and attention to detail
- High personal integrity, credibility, and energy
- Strong written and verbal communication skills
- Strong computer skills in Excel
Nice To Haves
- Experience in pharma/sterile manufacturing
- Experience in working with MES systems
- Adaptability
- Business Processes
- cGMP Guidelines
- Continuous Process Improvement
- Data Governance
- Electronic Batch Records
- GMP Compliance
- Laboratory Experiments
- Mammalian Cell Culture
- Oral Communications
- Personal Initiative
- Pilot Plant Operations
- Prioritization
- Process Engineering
- Process Improvement Projects
- Process Optimization
- Product Formulation
- Production Planning
- Regulatory Requirements
- SAP PP (Production Planning)
- Standard Operating Procedure (SOP) Writing
- Sterile Manufacturing
- Teamwork
- Technical Writing
Responsibilities
- Support the creation, maintenance, review, analysis, and accuracy of master data
- Assist in the sustainment, performance, and monitoring of standard business processes in all production execution and master data functions
- Support master data governance activities, including adherence to data standards, stewardship expectations, and escalation processes
- Gather, analyze, and report process performance and transactional discipline metrics to support compliance and continuous improvement efforts
- Collaborate with site and regional/global team members and participate as a member of the site CoP Team as needed
- Assist in the development and maintenance of SOPs and training materials and provide end user training support
- Identify, troubleshoot, and help resolve master data issues, escalating more complex issues as needed
- Participate in process improvement projects and support project planning, stakeholder coordination, and implementation activities
- Identify and support continuous process improvement opportunities and help promote best practices across the network
- Coordinate and share best practices with our company sites in the network
- Serve as a technical resource to team members by providing consultation, coaching, and practical support within area of expertise
- Assist in external agency inspections, as needed
- Support safety, compliance, and GMP initiatives
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
- annual bonus
- long-term incentive
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
