Address
Form of workJob Description
Job Description:
Pay Range: $50hour - $53hour
Responsibilities:
Pay Range: $50hour - $53hour
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.
- Provides excellent customer service and support.
- 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.
- Minimum 5 years of experience in FDA regulated industry, with 3 years of experience in equipment qualification and computer system validations
- Excellent 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. Preferred experience with Kaye validators, BSCs, refrigerators, welders, etc.
- Experience executing equipment qualification documents.
- Ability to interact effectively with laboratory, QA, and Facilities groups.
- Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion.
- Ability to effectively manage multiple tasks and activities simultaneously
- Strong written and verbal communication skills along solid presentation skills. Proficient at writing well-formulated emails and reports.
- Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task.
- Ability to effectively communicate with employees, contractors and vendors. Experience with technical writing and document development / generation.
- 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.
- Action and detail oriented.
- Active Listening.
- Decisive.
