Manufacturing/Validation - Change Management Specialist

100% onsite

PURPOSE AND SCOPE OF POSITION:
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: Knowledge, Skills, and Abilities:

• 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 (EBR), 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 WebMethods 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:
Responsibilities include, but are not limited to, the following:

• 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 risks that may put the site manufacturing systems at risk. Responsible for escalation and mitigation of such.

• Supports the maintenance of the validated state of Site Manufacturing Systems by ensuring compliance with global and site policies and standards

Continuously integrates with the business to understand current business processes and to provide technical guidance that enables and supports plans and strategies.

• Work closely with Manufacturing, Quality, Supply Chain, IT, MSAT groups, etc., and serve as applicable Manufacturing System Business Owner.

• Work closely with colleagues to ensure alignment of key program activities and milestones for deployment and production releases.

• Works closely with business owners to establish and maintain service level expectations across all functions and site manufacturing systems.

• Works closely with business owners, IT, Quality, network, and global partners to implement site lifecycle strategies aligned with Client CSV and GAMP guidance.

Supports business and compliance objectives by ensuring projects, systems lifecycle management, and technology service activities deliver high quality, service, and cost-effectiveness.

• Supports daily operations and enhancements of validated site manufacturing systems.

• Supports the creation and delivery of assigned 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., Scheduling UAT execution, defect management, and resolution.

• Anticipates and prioritizes activities that support quality, service, and cost-effectiveness based on a risk-based approach.

• Works closely with operational support and delivery teams to ensure post-production support model and process implementation.

• Performs other tasks as assigned.

Identify and capitalize on opportunities for continuous improvement.

• Support the change initiatives and the implementation of process improvement initiatives.

• Foster strong inter-team relationships to achieve common goals.

• Promotes an environment of continuous quality and improvement of processes, standards, and procedures.

WORKING CONDITIONS (US Only):

• The incumbent will work in an office environment, potentially requiring ergonomic considerations.

• The incumbent will be required to work in a conference room environment for moderate periods.

• The incumbent will be required to work in the manufacturing labs, production areas, or warehouses requiring gowning.

• The incumbent may travel between company sites for training, meetings, or corporate events on occasion.

• The incumbent will be expected to work non-standard work hours, including weekends and/or holidays, to support high-priority project deadlines or emergency efforts impacting delivery.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.

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