Other Locations:US- NJ- Warren
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Maintains all qualified equipment systems in compliance with policies, guidelines and procedures.
- Develops and approves change controls, validation plans, qualification protocols, associated reports and documents.
- Leads the execution of equipment qualifications, validation protocols, and process improvement studies.
- Initiates and leads investigations into qualification failures, and develops / implements remediation plans
- Supports compliance with Facilities Services Qualification Master Plan
- Oversees vendors for qualification and metrology functions.
- Initiates, guides and reviews written procedures for calibration and preventive maintenance of equipment
- Mentors and trains validation engineers and equipment engineers in equipment qualification and validation techniques.
Initiates, manages and leads cross-functional/cross-site projects of small to medium scope and complexity.
- Manages laboratory computerized system implementation projects including scheduling, site prep, installation, validation, and turn over to business area.
- Provides expert guidance to internal customer groups in the procurement, operation, and compliance aspects of computerized systems and other equipment to meet business needs in accordance with required schedules or dates.
- Assists facilities with new construction and relocation projects which involve computerized systems.
- Reviews and approves calibration, qualification and validation documentation for accuracy, completeness and compliance to Celgene standards.
- Provides strong technical knowledge and direction as Laboratory Systems Management site representative during interactions with all cross functional groups, as required.
Promotes and provides excellent customer service and support.
- Regularly reviews, prioritizes, coordinates and promptly responds to customer equipment qualification, system validation, and support requests.
- Provides expert technical support and guidance on calibration, equipment qualification and validations issues, and may advise senior management on courses of action, as required. Interfaces with customers to ensure all expectations are being met.
- Maintains a positive relationship with all the members of the Laboratory Systems Management department, Quality Control operations department, and site customers while promoting a positive team environment.
Promotes and maintains compliance with corporate, safety and regulatory policies.
- Maintains all required Corporate, Facilities and EHS training as required
- Champions adherence to and improvement of all safety procedures and hazard communication
Required Competencies-Knowledge, Skills, and Abilities:
Knowledge, Skills & Abilities:
- Strong knowledge of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry
- Expert knowledge of 21 CFR Part 11 compliance and Celgene Data Integrity policy requirements
- Strong knowledge and experience with the operation and qualification of pharmaceutical laboratory, facilities and manufacturing systems
- Strong experience writing and executing system validation & equipment qualification documents
- Extensive experience training group members and contractors on procedures, policies and other documents
- Ability to interact effectively with laboratory personnel, QA, and Facilities groups
- Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. 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 excellent verbal communication skills along with excellent leadership skills that encourages empowerment and ownership within the team and organization. Extremely 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. Strong experience with technical writing and document development / generation
- Innate ability to learn new software as required for equipment qualification and system validations.
- Expertise in the evaluation of new computerized systems in an effort to identify compliance gaps early on in the process and implement mitigations to ensure the highest quality standards are met.
- Technical / Professional Knowledge
- Problem Solving / Troubleshooting
- Project Management
- Action Oriented
- Attention to Detail
- Building Relationships
Education & Experience:
- BS degree in Engineering or equivalent
- Minimum 10 years of experience in FDA-regulated industry, with 7 years’ experience in system validation.
Physical / Mental Demands:
- Occasional stooping, bending, stretching , pushing, pulling, reaching and/or lifting up to 50lbs
- Ability to sit, stand, walk and move within workspace for extended periods
- Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling
- Ability to climb ladders and work in elevated areas.
- Ability to work extra hours on limited occasions in order to meet deadlines
- Minimal travel in North America
- Environment may include working in office or in a laboratory / manufacturing area.
- Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
- Ability to work safely in an environment with exposure to high temperature / pressure steam, and other fluids, compressed gasses, odors, various noise levels, moving parts, vibration, wet/slippery areas and high voltage energy supplies
- Environment may include working at heights, in cold temperatures, and/or constricted spaces
Ability to work safely when working alone, or working with others.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.