Address
Form of workImmediate need for a talented Manufacturing/Validation - Change Management Specialist . This is a 12+ Months contract opportunity with long-term potential and is located in Morris Avenue Summit, NJ (Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID: 23-51066
Pay Range: $50 - $53/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key 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-Client, 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.
- 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.
- 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.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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