Lead Engineer, Lab Systems Management Job|
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||Nov 15, 2017
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||US - New Jersey - Summit
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.
The Lead Engineer supports the successful operation of facility, laboratory and business functions at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, identifies issues or unmet needs and initiates projects or programs to address them. This individual works independently to complete assignments and oversees the successful completion of tasks. Using solid analytical skills, the incumbent is able to recognize problems of moderate scope and complexity, and independently, develop potential solutions and courses of action. This individual represents the work group on multi-disciplinary and cross-functional teams and uses established relationships to influence and lead teams and stakeholders with fact-based, business value knowledge.
Maintains all qualified equipment systems in compliance with policies, guidelines and procedures.
• Develops and approves change controls, validation plans, qualification protocols, associated reports and procedures.
• Executes equipment qualifications, validation protocols, and process improvement studies.
• Schedules and performs periodic field review of qualified systems
• Conducts investigations into qualification failures, and develops and implements remediation plans
• Supports compliance with Facilities Services Qualification Master Plan
• Contracts with and supervises vendors for qualification and metrology functions.
• Provides guidance and reviews written procedures for calibration and preventive maintenance of equipment
• Mentors and trains validation specialists and metrologists in calibration, equipment qualification and validation techniques.
Initiates, manages and leads projects of moderate scope and complexity within their functional area.
• Manages laboratory equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
• Provides guidance to internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.
• Oversees / supports facilities new construction and relocation projects.
• Reviews all calibration, qualification and validation documentation for accuracy, completeness and compliance to Celgene standards.
• Provides 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 and support requests.
• Provides technical support and guidance on calibration, equipment qualification and validations issues. Interfaces with customers to ensure all expectations are being met.
• Maintains a positive relationship with all the members of the Laboratory Systems Management 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
• Adheres to all safety procedures and hazard communication
Knowledge, Skills & Abilities:
• Strong understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry
• Proficient in 21 CFR Part 11 compliance
• Direct knowledge and experience with the operation and qualification of pharmaceutical laboratory, facilities and manufacturing systems
• Experience writing and executing equipment qualification documents
• Experience in managing resources and budgets as required for validation projects
• Experience training group members and contractors on procedures, policies and other documents
• Ability to interact effectively with laboratory, QA, and Facilities groups
• Strong 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
• Highly proficient in Microsoft Office Suite – Word, Excel and Outlook, and the innate ability to learn new software as required for equipment qualification.
Education & Experience:
• BS degree in Engineering or equivalent
• Minimum 7 years of experience in FDA-regulated industry, with 5 years’ experience in equipment qualification.
• 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.
Req ID: 16002168
Primary Location: United States-New Jersey-Summit
Organization: Celgene Corporation
Employee Status: Individual Contributor
Job Type: Full-time
Job Level: Day Job
Job Posting: 2017-01-05 00:00:00.0