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Validation Qualification Specialist
$85k-107k (estimate)
Full Time
Just Posted
Cynet Systems is Hiring a Validation Qualification Specialist Near Warren, NJ
Job Description:
Pay Range: $49hr - $52hr
Responsibilities:
Pay Range: $49hr - $52hr
Responsibilities:
- Maintains all qualified equipment/systems in compliance with policies, guidelines, and procedures.
- Develops qualification protocols, and associated reports while adhering to a change management process.
- Supports the execution of equipment/systems qualifications and validation protocols.
- Supervises vendors for qualification functions.
- Develops written procedures for calibration and preventive maintenance of equipment and systems.
- Supports calibration, equipment qualification and system validation activities.
- Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.
- Manages projects of limited scope and complexity within their functional area.
- Supports laboratory equipment/systems implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
- Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment/systems to meet business needs in accordance with required schedules or dates.
- Completes all calibration, qualification and validation documentation with accuracy, completeness, and compliance to company standards.
- Regularly reviews, prioritizes, and promptly responds to customer equipment qualification/system validation and support requests.
- Provides technical support and guidance on calibration and equipment qualification issues.
- Interfaces with customers to ensure all expectations are being met.
- Maintains a positive relationship with all team members and site customers while promoting a positive team environment.
- B.S. degree in Engineering or equivalent required.
- Minimum 5 years of experience in FDA - regulated industry, with 3 years of experience in facility/utility/equipment qualification required.
- Lab w/o blood & animal.
- Excellent technical writing skills and proficiency with Microsoft Word formatting functions; ability to efficiently create technically accurate documents for system lifecycle deliverables in alignment with the site validation program; highly attentive to spelling, grammar, punctuation, and overall document quality.
- Process oriented with solid critical thinking skills; adaptive and able to develop new/improved strategies, approaches, and procedures.
- Strong understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry.
- Familiarity with 21 CFR Part 11 compliance.
- Knowledge of pharmaceutical laboratory and manufacturing systems, utilities, and facilities.
- Preferred protocol execution experience with controlled temperature units (Kaye validators, Ellab), biological safety cabinets (cleanroom foggers), cryogenic storage systems, etc.
- Experience writing and executing commissioning/qualification/validation documents including VMP, URS, FAT, SAT, IOPQ, RTM, and summary reports.
- Experience writing protocol deviations, investigating out of specification results, and performing corrective and preventive actions.
- bility to interact effectively with cross-functional groups.
- Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion.
- bility to effectively manage multiple tasks and activities simultaneously.
- Strong written and verbal communication skills, including solid presentation skills.
- Proficient at writing well-formulated emails and reports.
- bility to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task.
- bility to effectively communicate with employees, contractors and vendors.
- Strong computer skills in Microsoft Office Suite - Word, Excel and Outlook, and the ability to learn new software as required for equipment qualification.
- Professional Knowledge.
- Problem Solving.
- Team Player / Building Relationships.
- Multi-tasking.
- Customer Focus.
- ction and detail oriented.
- ctive Listening.
- Decisive.
Job Summary
JOB TYPE
Full Time
SALARY
$85k-107k (estimate)
POST DATE
06/19/2024
EXPIRATION DATE
07/03/2024
WEBSITE
cynetsystems.com
HEADQUARTERS
ARCOLA, VA
SIZE
500 - 1,000
FOUNDED
2010
CEO
ASHWANI MAYUR
REVENUE
$50M - $200M
INDUSTRY
IT Outsourcing & Consulting
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