CSV Engineer - South Plainfield, United States - Katalyst Healthcares & Life Sciences

Katalyst Healthcares & Life Sciences South Plainfield, United States

4 weeks ago

OTHER

Description

Roles & Responsibilities:

Authors, executes and/or reviews validation documents such as validation project plans, validation protocols, validation reports, risk management tools, gap analysis, CAPA and validation exceptions/deviations for Computer and IT systems.

Expertise in MES/Delta-V/LIMS/Lab Equipment and Manufacturing CSV systems.

Schedules and executes validations per ASTM, GAMP V, standard operating procedures and regulatory guidelines.

Lead assigned validation related investigations and conduct data integrity (DI) assessments with DI remediation planning.

Champion and lead continuous improvement efforts on every aspect of validation

Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.

Foster cross-departmental relationships (QC, Materials Management, IT, Manufacturing, QA and site leadership) by representing Validation at team meetings.

Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.

Demonstrate technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGxP, CFR 21 Parts 11, 210, 211, ICH Q7, Q8, Q9 and applicable regulations and industry standard procedures.

CSV Engineer

5 days ago

Katalyst HealthCares & Life Sciences South Plainfield, United States

Key Responsibilities: · Experience and in-depth understanding of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents through System Retirement. · This includes deliverables such as Planning (Project Validation ...
CSV Engineer

1 week ago

Katalyst Healthcares and Life Sciences South Plainfield, United States

*Role: This work will be full on-site in North Carolina. This Consultant will be working on Computer Systems, Building out CSV Protocols. Must have experience executing CSV protocols. 21 CFR Part 11 experience is needed. The type of Laboratory Systems are LIMS, SCADA, etc. Client ...
CSV Engineer

3 weeks ago

Smart Bot Systems Somerville, United States

Job Description · Job Description · Hope you are doing well. · Please go through the job description. If you are fine, please share your updated resume. · Role: · CSV Engineer · Location: Raritan, NJ (Hybrid) · Type: Contract · Job Description: · Roles and Responsibilities · ...
CSV Engineer

6 days ago

Advanced Accelerator Applications USA, Inc. Millburn, United States

Advanced Accelerator Applications USA Inc. has openings for CSV Engineer in Milburn, NJ: Develop, execute, review, and approve validation protocols and reports and coordinate CSV work execution with various departments and contractors. Execute and/or oversee work required to CSV ...
CSV/QA Engineer

2 weeks ago

Xyntek, Inc Rahway, United States Contract

About us · Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies ...
CSV Engineer

3 weeks ago

Novozen Healthcare LLC Raritan, United States

Role: CSV Engineer · Location: Raritan, NJ · Roles and Responsibilities: · 7+ years of CSV experience with exposure in SAP ECC/S4 HANA system validation, Solman/ChaRM change control process, JIRA/XRAY/qTEST tools for validation required. · Working Knowledge of regulations: 21 C ...
CSV Engineer

3 weeks ago

Novozen Healthcare LLC Raritan, United States

Role: CSV Engineer · Location: Raritan, NJ · Roles and Responsibilities: · 7+ years of CSV experience with exposure in SAP ECC/S4 HANA system validation, Solman/ChaRM change control process, JIRA/XRAY/qTEST tools for validation required. · Working Knowledge of regulations: 21 CF ...
CSV Engineer

2 weeks ago

AppLab Systems Inc Raritan, United States

Hi, · Hope you are doing good... · I am Baiju represented to Applab Systems and I have an excellent job opportunity for you. Please find the below job description and if you are comfortable, please reply or contact me for further discussion. · Job Title: CSV Engineer · Location: ...
CSV Engineer

1 week ago

Phibro Animal Health Teaneck, United States

Press Tab to Move to Skip to Content Link · Select how often (in days) to receive an alert: · About Phibro Animal Health Corporation · Phibro Animal Health Corporation is a publicly traded organization with a rich history spanning nearly 100 years of service. The Company is a glo ...
CSV Engineer

3 weeks ago

DPS Group Global New York, United States

Summary · DPS Group is seeking an enthusiastic and experienced computer system validation engineer to join our team. The Computer System Validation Engineer will be responsible for the Computer System Validation of IT solutions being implemented for a continuous manufacturing fa ...
CSV Engineer

4 weeks ago

eTeam Raritan, United States

Minimum 7 years in CSV required. · Experience in Validation and Testing (UAT, Regression Testing) · Experience in leading application profile, operational requirements, business process and other project knowledge, as required, to provide the Services Experience creating detail ...
CSV Engineer

4 weeks ago

Katalyst Healthcares & Life Sciences Raritan, NJ, United States

Responsibilities: 3+ years' Experience in Validating MES or Manufacturing an Lab systems. Experienced in CSV activities in Manufacturing related applications like SAP Systems, MES systems or Lab related systems in the manufacturing space. Perform review for GxP systems to ensure ...
CSV Engineer

1 week ago

Katalyst HealthCares & Life Sciences Raritan, United States

Responsibilities: · 7+ years of experience in Computer System Validation. · Reviewing and approving validation deliverables of GxP regulated Computerized Systems to ensure full compliance with Health Authority regulatory requirements and adherence to company policies and proced ...
Project Lead

6 days ago

eTeam Inc Rahway, United States

$60-65/Hour. · Familiarity on Commercial Off the Shelf Lab systems, · Windows Server environment, · Network experience. · Role Description: · Provide hands-on end user support, administration, installation, and issue resolution for GxP controlled laboratory equipment, servers, de ...
MSEO Manufacturing Systems Validation Specialist

1 day ago

OMG Technology New Brunswick, United States

Job Description · Job DescriptionSalary: $55/hr. W2 · MSEO Manufacturing Systems Validation Specialist (Summit West, NJ - ONSITE) · We are looking to hire a candidate with the skill sets mentioned and experience for one of our clients within the pharmaceutical industry. This posi ...
PLC/ Delta V Automation Engineer with a Background in Pharma

2 weeks ago

Combined Computer Resources Rahway, United States

THIS IS A HANDS-ON TECHNICAL ROLE. REVERSE ENGINEERING, CODING, ELECTRICAL WIRING. SUPPORTING DELTA V IN A PILOT PLANT. THE SENIOR SPECIALIST - MANUFACTURING AUTOMATION POSITION WILL REPORT DIRECTLY TO THE AUTOMATION LEAD AND WILL BE A MEMBER OF THE EDM TEAM. DIRECT SUPPORT OF TH ...
Associate Director, Manufacturing Systems IT

3 weeks ago

Legend Biotech US Somerset, United States

Company InformationLegend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including aut ...
Information Technology Business Analyst

3 weeks ago

Insight Global Rahway, United States

Compensation: · $60/hr to $70/hr · Exact compensation may vary based on several factors, including skills, experience, and education. · Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, ...
Associate Director, Manufacturing Systems IT

3 weeks ago

Legend Biotech US Somerset, United States

Company Information · Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including ...
Specialist, MSEO Manufacturing Systems Validation

1 hour ago

Diversity Nexus Summit, United States

Job Title: Specialist, MSEO Manufacturing Systems ValidationJob Location: Summit West, NJ (need local candidates only)Job Duration: 6 monthsEmployment Type: w2 hourlyRequiredMinimum 50% onsite required every week(Candidate is supposed to align the onsite days with manager and be ...