ATL02-011326 CQV Specialist (Automation CSV Laboratory) NC
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Job Location:
Duluth, MN - USA
Monthly Salary:
Not Disclosed
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
Validation & Engineering Group Inc. (V&EG) is a leading technical services provider specializing in Commissioning & Qualification (C&Q) Computer System Validation (CSV) Validation Compliance Quality Assurance and Engineering services for the Biotechnology Pharmaceutical Advanced Therapies Medical Device and Chemical (API) industries.
We are seeking an experienced and technically strong CQV / CSV Specialist with a primary focus on Automation and Manufacturing Systems to support FDA-regulated manufacturing operations at a client site in North Carolina.
POSITION OVERVIEW
This role is CSV and automation-focused working directly with the clients automation and manufacturing systems teams. The individual will be responsible for assessing validating and qualifying changes to previously qualified automated manufacturing lines and systems within an FDA-regulated environment.
Manufacturing lines include:
- Liquid and lyophilized vial lines with RABS technologies
- Fully isolated syringe and vial combination lines
- Highly automated and robotic manufacturing systems
In addition to automation and manufacturing systems the role may also provide CQV support for laboratory systems when needed.
KEY RESPONSIBILITIES
- Lead and execute Computer System Validation (CSV) and automation-related qualification activities for manufacturing systems.
- Assess document and qualify changes to previously qualified manufacturing lines equipment and automated systems.
- Support and validate PLC changes SCADA changes and automation system modifications.
- Perform automation validation including understanding and assessing PLC logic and programming.
- Collaborate closely with automation engineering and manufacturing teams.
- Support qualification and validation of:
- Automated manufacturing process equipment
- Cleanroom Building Management Systems (BMS)
- Clean utilities and related control systems
- Select IT-related systems as applicable
- Author execute and review validation documentation (IQ OQ PQ CSV deliverables) in compliance with cGMP FDA EMA and site requirements.
- Perform risk assessments discrepancy resolution deviation investigations and support change control and CAPA activities.
- Provide clear project status updates and support timely release of systems for manufacturing use.
- Support laboratory systems CQV activities as needed.
QUALIFICATIONS
- Bachelors degree in engineering computer science life sciences or a related technical discipline.
- Minimum 5 years of experience in CSV automation validation and CQV within pharmaceutical biotech or other FDA-regulated environments.
- Hands-on experience with:
- PLC-controlled systems
- SCADA systems
- Automation change management and validation
- Strong understanding of:
- Automated manufacturing process equipment
- CSV principles and lifecycle documentation
- cGMP 21 CFR Part 11 EU Annex 11 data integrity requirements
- Experience supporting complex manufacturing systems including robotic or highly automated lines.
- Experience with aseptic manufacturing operations (filling lyophilization isolators RABS).
- Strong technical writing organizational and communication skills.
- Ability to work independently in a fast-paced on-site manufacturing environment.
Required Experience:
IC
Key Skills
- Controlling Experience
- Distributed Control Systems
- Pardot
- Crystal Reports
- Marketing Automation
- Salesforce Marketing Cloud
- Warehouse Management
- HubSpot
- Responsys
- Email Marketing
- Leadership Experience
- Programmable Logic Controllers
About Company
Validation & Engineering Group Proudly serving our clients since 1997 Validation & Engineering Group provides world-class service and expertise to the Biotechnology, Food Safety and Quality, Medical Devices, and Pharmaceutical Industries. We offer our clients: Validation, Control Syst ... View more
