Manufacturing​/Validation - Change Management Specialist

Specialist, MS&T Manufacturing Systems Engineering and Operations – Change and Release Management

The Specialist, MS&T Manufacturing Systems Engineering and Operations – Change and Release Management is responsible for executing Change and Release Management initiatives, project plans, implementation strategies, technical and documentation tasks, and supporting verification and testing activities, compliant delivery, and operation 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, Automation Systems, Manufacturing Execution Systems (Enterprise and legacy MES systems), Change and Release Management, and Continuous Improvement tools.

The position requires knowledge of Manufacturing Systems, SDLC methodologies, Computer System Validation (CSV), Computer System Assurance (CSA), Data Integrity (ALCOA+), and project management methodologies. The incumbent must be independent, goal-oriented, flexible, able to work efficiently across multiple projects, enthusiastic, and innovative, with a basic understanding of change and release management and critical thinking. Works under the guidance of lead team members.

Required Competencies:

• Advanced time management skills, including prioritizing and managing expectations in a fast-paced working environment.
• Intermediate proficiency in Microsoft Word, Excel, and Visio.
• Intermediate technical writing skills
• Basic knowledge of GMP manufacturing
• Basic knowledge of Change Management
• Basic presentation development and delivery skills
• Critical reasoning and decision-making skills.
• Ability to translate strategy into actions.
• Ability to work independently and in cross-functional teams.
• Operate effectively and with minimal supervision within a team or independently, performing projects and related duties.
• Knowledge of Manufacturing Systems Technologies and Computer Systems Validation with an ability to assess the impact and feasibility of system changes.
• Working knowledge of Computer Systems Validation with an ability to author and peer review validation, verification, and operational (SOP) deliverables in biotechnology/pharmaceutical or related industries.
• Working knowledge of Electronic Batch Records (E ), Review by Exception (RBE), and MES Recipe object lifecycle management preferred.
• Familiarity with MES infrastructure, Client ALM, Electronic Document Management Systems, Change Management Systems, and middleware Web Methods preferred.

Education and Experience:

• Bachelor's degree required in Engineering, Biological/Life Sciences, Chemistry, Biochemistry or related field, or equivalent combination of education and work experience.
• Two (2) or more years of relevant work experience required in manufacturing support or related experience in the biotechnology/pharmaceutical industry.
• Cell Therapy experience preferred. Understanding cell culture, cryopreservation, purification, aseptic processing or lab technique, Packaging, Shop floor quality, batch review, or disposition preferred.
• Experience with MES, ERP, LIMS, or other manufacturing boundary systems and technologies preferred.

Duties and Responsibilities:

• Responsible for technical and operational support for the Manufacturing Systems Change and Release Management activities, including documentation, recipe assessment, and change management tasks.
• Responsible for participating in developing, implementing, and maintaining site procedures and policies for Manufacturing Systems lifecycle management, aligning with Client processes, and delivering and maintaining validated technologies suitable for commercial manufacturing.
• Ensure completion of all business and system cutover activities.
• Participates in Technical Designs, Prototypes/Mock-ups, Development, Testing, and Delivery of solutions for Release Cycles and/or new projects within the manufacturing systems stack.
• Creates and coordinates the deployment communication plans, including "Go Live" readiness, change management, cutover, and stabilization.
• Employs a general understanding of lifecycle management to identify issues and…