Job Title: Validation Qualification Specialist

　　Location: Warren, NJ

　　Hours/Schedule: Mon - Fri, Business Hours

　　Compensation:

　　Type: Contract

　　Responsibilities

　　1) 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.

　　2) 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 BMS standards.

　　3) 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.

　　Requirements

　　Knowledge, Skills & Abilities:

　　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.

　　Competencies:

　　Professional Knowledge

　　Problem Solving

　　Team Player / Building Relationships

　　Multi?tasking

　　Customer Focus

　　Action and detail oriented

　　Active Listening

　　Decisive

　　EDUCATION AND EXPERIENCE

　　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.

　　Benefits

　　System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

　　System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

　　System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.