Manufacturing Systems Validation
5 days ago
Job ID # 81193
Minimum 50% onsite required every week
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 BMS procedures, such as CSV SOP but no limited and applicable health authority regulations.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
• 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 12x7 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
Education and Experience: • Bachelor's degree in a life sciences, engineering or technology discipline required
• Minimum of 2+ years relevant work experience required preferably in a pharmaceutical manufacturing environment.
• An equivalent combination of education, experience and training may substitute.
-
Summit, United States Aequor Full timeValidation - Specialist, MSEO Manufacturing Systems ValidationSummit, NJJob Requirements:Onsite Requirement: Minimum 50% onsite required every week (Candidate is supposed to align the onsite days with the manager and be available onsite when the manager requests).Education: Bachelor’s degree required in Life Science or Engineering.Duration: 6 months...
-
Summit, United States ASK Consulting Full time"All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".Job Title: Specialist, MSEO Manufacturing Systems ValidationLocation: Summit, NJDuration: 6 months Pay rate: $55 to $57 W2 Deal Job Description:The Specialist works cross-functionally to execute...
-
Validation Specialist
7 days ago
Summit, United States Joulé Full timeJob Title: Validation SpecialistHave you got what it takes to succeed The following information should be read carefully by all candidates. Location: Summit, NJ (Hybrid) Hours/Schedule: Monday - Friday; 1st Shift Type: Contract Overview Global Pharma company looking for experienced Validation Specialist to join their growing team. No C2C. ...
-
Pipefitter - Manufacturing
3 months ago
Browns Summit, United States Environmental Air Systems, LLC Full timeJob DescriptionJob DescriptionEnvironmental Air Systems is one of the leading industrial HVAC engineering, manufacturing, and construction companies in the southeastern United States. We are growing rapidly and seeking skilled Pipefitters to join our Final Assembly department in our manufacturing plant in Browns Summit, North Carolina.BENEFITS:Weekly PayFull...
-
Validation Specialist
6 days ago
Summit, NJ, United States Joulé Full timeJob Title: Validation Specialist Location: Summit, NJ (Hybrid) Hours/Schedule: Monday - Friday; 1st Shift Type: Contract Overview Global Pharma company looking for experienced Validation Specialist to join their growing team. No C2C. Responsibilities Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE) and Recipe...
-
Pipe Welder
3 weeks ago
Browns Summit, North Carolina, United States Environmental Air Systems, LLC Full timeJob OpportunityEnvironmental Air Systems, LLC is seeking skilled Pipe Welders to join our Final Assembly department in our manufacturing plant in the southeastern United States.We offer a competitive salary of $60,000 - $80,000 per year, depending on experience and qualifications.About the RoleAs a Pipe Welder, you will be responsible for welding various...
-
Summit, United States Mindlance Full timeJob Description: Job Title: Quality - Business Systems Analyst Location: Princeton Pike or Summit, NJ. *Hybrid OR 100% Onsite* Top Skills: - SAP analyst with some IT Background - Experience Training internal and external end users - Writing test scripts as well as SOP and work instructions - System implementation experience - Cell therapy / Biotech exp....
-
Business Systems Analyst
2 weeks ago
Summit, United States Integrated Resources Full timeJob Title: Quality - Business Systems Analyst Location: Princeton Pike or Summit, NJ. *Hybrid OR 100% Onsite*Top Skills: SAP analyst with some IT Background Experience Training internal and external end users Writing test scripts as well as SOP and work instructions System implementation experience Cell therapy / Biotech exp. preferred Overview The SAP...
-
Business Systems Analyst
3 weeks ago
Summit, United States TSR Consulting Full timeAbout 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...
-
Quality - Business Systems Analyst
3 weeks ago
Summit, United States Futran Tech Solutions Pvt. Ltd. Full timeJob Description: Job Title: Business Systems Analyst Location: Libertyville*100% Onsite Top Skills: • Expert in SAP S4/Hana, specifically Production Planning, specifically in BOM/Master Recipe • Adept in supporting in SAP S4/Hana and non- SAP S4/Hana system. • Experience Training internal and external end users • Writing test scripts as well as SOP...
-
Summit, United States Omni Inclusive Full time100% onsite PURPOSE AND SCOPE OF POSITION: The Training & Development Specialist is responsible for the successful implementation of the site Manufacturing Training Program. The Specialist assists in determining training solutions that adhere to the Site Training Program. This position trains other staff members, as well as assesses their ability to perform...
-
Supply Chain Business Analyst
3 weeks ago
Summit, United States Sunrise Systems, Inc. Full timeJob Title: Supply Chain Business Analyst- SAP S4 HanaLocation: Summit, NJDuration: 12 Months contract on W2Summary:The Cell Therapy External Manufacturing ERP Systems business analyst is part of the Cell Therapy Vector & External Manufacturing Operations (VEXMO) organization and will support the ERP business process for the external network. This role is...
-
SAP S4/Hana Business Systems Analyst
3 weeks ago
Summit, United States LanceSoft Full timeJob Title: Business Systems Analyst Location: Libertyville, IL 60048 (100% Onsite) Duration: 12 MonthsTop Skills: Expert in SAP S4/Hana, specifically Production Planning, specifically in BOM/Master Recipe Adept in supporting in SAP S4/Hana and non- SAP S4/Hana system. Experience Training internal and external end users Writing test scripts as well as SOP and...
-
Manager, Advanced Manufacturing Engineer
2 weeks ago
Summit Argo, United States Dover Corporation Full timeManager, Advanced Manufacturing Engineer - Machining at Dover Corporation summary: The Manager of Advanced Manufacturing Engineering - Machining at Dover oversees the optimization of machining processes and ensures the efficient use of equipment and design specifications. This role involves leading initiatives to improve operational efficiency, managing...
-
Business Systems Analyst Lead
5 days ago
Summit, New Jersey, United States Mindlance Full timeCompany Overview: Mindlance is a service-oriented company that supports businesses with technology investments. We're looking for a skilled professional to join our team as an SAP S4/Hana Business Delivery Lead Systems Analyst.Salary and Benefits: The estimated hourly compensation for this assignment is between $60-$90. Mindlance offers competitive benefits...
-
Supply Chain Business Analyst- SAP HANA
4 weeks ago
Summit, United States Sunrise Systems, Inc. Full timeJob Title: Supply Chain Business Analyst- SAP HANA Job ID: 24-05300 Location: Summit, NJ, 07901 Duration: 12 Months contract on W2 Job Description: Minimum 50% onsite required (candidate need to be flexible to come more than 50% if needed) Work Schedule: Mon-Fri (normal business hours) Summary: The Cell Therapy External Manufacturing ERP...
-
Summit, United States Synectics Full timeJob Description: The SAP S4/Hana Business Delivery Lead Systems Analyst is a service oriented, positive, forward thinking team member, who is responsible for implementing and supporting SAP solutions to meet business-related requirements. Act as a liaison between a third party support team and end users to ensure technical compatibility and satisfaction of...
-
Industrial Electrician
3 weeks ago
Browns Summit, North Carolina, United States Banknote Corp of America Full timeJob OverviewWe are seeking a skilled and reliable Industrial Electrician to join Banknote Corp of America in North Carolina. As an Industrial Electrician, you will be responsible for installing, maintaining, troubleshooting, and repairing electrical systems and equipment in industrial settings.Key Responsibilities:Install, maintain, and repair electrical...
-
Electrical Installation Specialist
3 weeks ago
Browns Summit, North Carolina, United States Environmental Air Systems, LLC Full timeAbout the RoleEnvironmental Air Systems, a leading mechanical contractor, is seeking skilled Electricians to join our Manufacturing Team in Browns Summit, North Carolina. As an Electrical Installation Specialist, you will be responsible for performing daily manufacturing tasks with minimal supervision in the Final Assembly department. You will work...
-
Advanced Manufacturing Engineer
4 weeks ago
Summit Argo, IL, United States Dover Corporation Full timeDover is a diversified global manufacturer with annual revenue of over $8 billion. We deliver innovative equipment and components, specialty systems, consumable supplies, software and digital solutions, and support services through five operating segments: Engineered Products, Clean Energy & Fueling, Imaging & Identification, Pumps & Process Solutions and...