- Location: Summit, New Jersey
- Type: Contract
- Job #79179
- The Specialist works cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing. This role is primarily an individual contributor but will routinely support project and production works.
- The Specialist will partner with site Business Owners, CI Owners, Quality, and the global EMES team to create, manage, and improve computerized systems/Recipes validation deliverables for electronic systems, applications, and associated controls to maintain data integrity supporting ALCOA+ principles throughout the CSV lifecycle.
- The Specialist will be responsible for ensuring the validation of the S12 Enterprise Manufacturing Execution System (EMES), and applications are done following the relevant company procedures, such as CSV SOP but no limited and applicable health authority regulations.
- Bachelor's degree in a life sciences, engineering or technology discipline required.
- 2 years relevant work experience required preferably in a pharmaceutical manufacturing environment.
- An equivalent combination of education, experience and training may substitute.
- Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE) and Recipe Authoring/Validation.
- Ability to work extended hours or a modified work schedule to assist manufacturing operations support model, including 12×7 on-call support rotation.
- Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA+ principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principles.
- Understanding the concept of Critical thinking for Computerized Systems.
- Familiar with the development of CSV documentation (Validation Plans, Requirements, Design / Configuration Specifications, Test Scripts [IQ/OQ/PQ/UAT], Summary Reports, Trace Matrices, SOPs).
- Experience with MES infrastructure, ALM and Veeva document/change management systems and middleware WebMethods.
- With advanced technical document writing and time management skills, including ability to prioritize and manage expectations.
- Operate effectively and with minimal supervision, within a team or independently, performing projects and related duties.
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Specialist, MSEO Manufacturing Systems Validation - Summit, United States - TSR Consulting
Description
About TSR:TSR is a relationship-based, customer-focused IT and technical services staffing company.
For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.
Mission & Vision
We do not believe in building a vision around the company but building a company around our vision, which is simply;
Every employee's voice matters, their effort is appreciated, and their talent is rewarded.
We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.
Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.
Specialist, MSEO Manufacturing Systems Validation
Job Description
Job ID #: 79179
Work Location:
Summit, NJ - Hybrid role, 50% on site
Summary:
