Senior Validation Engineer, Computer Systems

Employer
Celgene
Location
Phoenix, Arizona, United States
Posted
Jan 10, 2019
Ref
1803719
Required Education
Bachelors Degree
Position Type
Full time
Req #: 1803719
Location: Phoenix, Arizona, United States
Job Category: Technical Development
Work Location: 620 N. 51st Avenue 85043
Organization: Manufacturing Services
Employee Status: Full-time
Job Type: Regular

SENIOR VALIDATION ENGINEER, COMPUTER SYSTEMS
Phoenix, AZ

Purpose and Scope of Position
The Senior Scientist, Computerized Systems, is responsible for performing computerized systems validation activities through the validation life cycle. Primary responsibilities include: qualification of process automation, laboratory instruments, databases, and IT infrastructure, and technical writing and execution. Serves as a subject matter expert in a GxP computerized systems and provides expert technical recommendations and compliance guidance for engineering, IT, and other technical groups. Leads validation projects, executes and manages system qualification, and implements industry best practices for the design and delivery of GxP computerized systems.

Required Competencies: Knowledge, Skills, and Abilities
  • Intermediate understanding of validation concepts and requirements.
  • Intermediate written and verbal communication skills.
  • Advanced knowledge and interpretation of cGMP.
  • Strong critical reasoning and decision making skills.
  • Working knowledge of validation industry and regulatory requirements.
  • Defend validation programs, processes, and protocols in internal and external audits.
  • Ability to work independently, lead and participate in a team.
  • Basic project management skills.
  • Intermediate proficiency in Microsoft Word, Outlook, Excel, PowerPoint, and Project.
  • Working knowledge of software quality assurance.

Duties and Responsibilities
  • Independently performs and/or leads team in Validation document generation, program management, and protocol execution activities.
  • Interface with Engineering, Validation, and end user groups as a subject matter expert to provide technical guidance with validation including, but not limited to, design and requirements development, software testing, system administration, data management, and riskmanagement.
  • Design the validation approach, provide the scientific rationale and acceptance criteria, generate and approve validation protocols.
  • Conduct and assist others in industry and regulatory research including research into industry standards/FDA guidelines for validation processes and make determinations regarding acceptance criteria and testing.
  • Own and execute complex protocols, projects, and activities.
  • Lead projects, prepare project schedules and execute validation studies, perform data analysis, and write protocol summaries, reports, and technical reports.
  • Perform protocol execution and validation activities, including collection of samples associated with qualification or ongoing support activities.
  • Coordinate with business process owners and other groups as needed to execute routine testing and validation on GxP computerized systems.
  • Conduct training for internal customers on protocols associated with validated equipment, systems, processes, and specifications.
  • Contribute to the design, implementation, and management of site programs related to periodic reviews, data governance, system administration, risk management, and software development.
  • Own department programs and SOPs, and generate revisions as required based on current industry standards and regulatory requirements.
  • Execute CAPA plans, risk assessments, investigations, and root cause analyses.
  • Working understanding of site quality GxP systems supporting document management, change controls, deviations, CAPAs.
  • Independently track own work and deliverables, with regular reporting to management.
  • Interact and collaborate with departments (on and offsite) as well as vendors, consultants and other external service providers.
  • Write and process change controls, assess impact to validated equipment, utilities, facilities, and processes.
  • Coordinate and lead other Validation Scientists in the work group and provide technical expertise related to validation approaches.
  • Perform general administrative and organizational activities.
  • Management of time and work deliverables, regular interface and reporting to management.
  • Complete regulatory, site, and department training requirements on a timely basis.
  • Performs other tasks as assigned.

Education and Experience
  • Bachelor's degree required, preferably in Science or Engineering.
  • 5 years relevant work experience required.
  • 4 years validation experience in a pharmaceutical or related manufacturing environment preferred.
  • An equivalent combination of education, experience and training may substitute.

Working Conditions
  • The incumbent may be required to gown and operate in classified manufacturing environments.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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About Us

COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.