Vacancy expired!
Our client, a leading pharmaceutical company is hiring a Validation Engineer on a contract basis. Work Location Summit, NJ
Summary Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures. • Develops protocols, and associated reports while adhering to a change management process. • Supports the execution of equipment qualifications and validation protocols • Supervises vendors for qualification functions. • Supports equipment qualification and systems validation activities. • Configures and documents the configuration of computerized systems • Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls. • Manages projects of varying scope and complexity. • Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area. • Independent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems • Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates. • Completes all qualification and validation documentation with accuracy, completeness and compliance to Celgene standards. • Provides excellent customer service and support. • Regularly reviews, prioritizes and promptly responds to customer equipment qualification 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.Required Competencies-Knowledge, Skills, and Abilities:Knowledge, Skills & Abilities: • Strong working knowledge of MS Windows client and server technologies. • Working knowledge of standard networking principles and technologies • Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry • Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance • Ability to work with the end user to identify and document User and Functional Requirements • Knowledge of pharmaceutical laboratory and manufacturing systems. • 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, Visio and Outlook, and the ability to learn new software as required for equipment qualification.Competencies: • Technical / Professional Knowledge • Problem Solving / Troubleshooting • Action Oriented • Attention to Detail • Multi-tasking • Building RelationshipsEducation & Experience: • BS degree in Engineering / Computer Science or equivalent • Minimum 5 years of experience in FDA-regulated industry, with 5 years experience in CSV- Apply Now
Vacancy expired!