Manager, Technical Specialist, Mseo Validation, Ms&T

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The Manager/ Technical Specialist of MS&T Manufacturing Systems Engineering and Operations - Validation leads and executes end-to-end validation activities for designing, developing, delivering, validating, maintaining, and supporting Manufacturing Systems (computer systems) for the Summit West Manufacturing Cell Therapy site.
The Manager/ Technical Specialist, working cross-functionally, is responsible for leading, establishing, enhancing, and maintaining validation deliverables for computerized systems, applications, and associated controls of Manufacturing Systems used across clinical and commercial value streams in the manufacture of cell therapy products, including:

• Labeling Solutions
• Manufacturing Execution tools
• Data acquisition and reporting systems
• Manufacturing Execution Systems (Enterprise and legacy MES systems)
• Validation process definition and Continuous Improvement

The position requires strong technical knowledge of Computer System Validation (CSV), Computer System Assurance (CSA), Data Integrity (ALCOA+), Manufacturing Execution Systems, project management skills, and stakeholder coordination.
The incumbent must be independent, goal-oriented, flexible, able to lead and work efficiently across multiple projects, enthusiastic, and innovative, with an expert understanding of validation and critical thinking to support the needs of the Site Manufacturing teams.
Knowledge, Skills, and Abilities:

• Demonstrate adept critical reasoning and decision-making capabilities.
• Exhibit proficiency in problem-solving and conflict resolution.
• Ability to coach, train, delegate, and motivate junior staff.
• Possess the ability to work autonomously and collaboratively within and across functional teams.
• Showcase hands-on experience in orchestrating end-to-end Validation Lifecycle Implementation for software systems.
• Advanced knowledge of Computer Systems Validation with an ability to author, review, and approve validation and verification deliverables in biotechnology/pharmaceutical or related industries.
• Advanced knowledge of Data integrity, cGMP, GXP regulations, and industry best practices for GxP computerized systems (GAMP, CSA, ALCOA, etc.).
• Advanced technical document writing.
• Exhibit effective time management skills, including effective prioritization and expectation management within a fast-paced work environment.
• Proficient in MS Office Applications.
• Working knowledge of Electronic Batch Records (EBR), Review by Exception (RBE), and MES Recipe object validation is preferred.
• Experience with MES infrastructure, HP ALM, Electronic Document Management Systems, Change Management Systems, and middleware (e.g., Web Methods) is preferred.

Education and Experience:

• Bachelor's degree in engineering, Biological/Life Sciences, Chemistry, Biochemistry, or a related field, or an equivalent combination of education and professional experience.
• Advanced degree preferred.
• 5-7+ years of relevant work experience required in the biotechnology/pharmaceutical or related industry.
• Cell Therapy experience preferred.

Duties and Responsibilities:
Provide leadership for assigned Manufacturing Systems Computer System Validation efforts and initiatives.

• Participate in maintaining the validated state of Site Manufacturing Systems to ensure global and site compliance with policies and standards.
• Promotes and enforces BMS standard systems, policies, and procedures across the full range of managed systems.
• Promotes an environment of continuous quality and improvement of processes, standards, and procedures.
• Responsible for planning to ensure the highest level of support for the site.
• Participate in supervising and coaching assigned validation resources to effectively support manufacturing systems validation and fulfill required validation responsibilities and tasks.
• Provides validation-related coaching and mentoring to maximize team effectiveness and cohesion.
• Responsible for the performance of assigned resources (as applicable).

Responsible for participating in developing, implementing, and maintaining site procedures and policies for Manufacturing Systems Validation, aligning with BSM CSV processes, and delivering and maintaining validated technologies suitable for commercial manufacturing.

• Works closely with business owners to establish and maintain service level expectations across all functions and site manufacturing systems.
• Works with business owners, IT, Quality, network, and global partners to execute site validation strategies aligned with BMS CSV and GAMP guidance.
• Identify and capitalize on opportunities for continuous improvement.
• Participates in internal audits and regulatory inspections as Manufacturing Systems Validation representative and assists in generating responses to audit/inspection observations (as assigned).

Champions business and compliance objectives by leading or supporting projects, systems lifecycle management, and technology service activities.

• Supports daily operations and enhancements of validated site manufacturing systems.
• Responsible for the execution of assigned tasks and deliverables on time and with high quality. Accountable for led efforts.
• Accountable for the planning, creation, review, and approval of validation documentation, e.g., Validation Plans, Requirements, Specifications (Design, Functional, Configuration), Test Scripts (IQ/OQ/PQ/UAT), Summary Reports, Trace Matrices, Standard Operating Procedures, and others.
• Responsible for coordinating User Acceptance Testing activities, e.g., training individuals as qualified UAT testers, scheduling UAT execution, defect management, and resolution.
• Works closely with Project Managers to develop detailed Project Plans related to validation tasks and deliverables.
• Anticipates and prioritizes activities that support quality, service, and cost-effectiveness based on a risk-based approach.
• Responsible for leading Change Control creation through implementation as part of the Quality Management System (as assigned).
• Responsible for supporting nonconformance and CAPA (as validation SME) as part of the Quality Management System (as assigned).
• Employs a high level of understanding of validation to identify issues and risks that may put the site manufacturing systems at risk. Responsible for escalation and mitigation of such.
• Performs other tasks as assigned.

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On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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