Computer System Validation Engineer
Pennsylvania All, PA
The computer system Validation Engineer Implements and maintains all validated computer systems in compliance with policies, guidelines and procedures. Through this work, the validation 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. The incumbent will be involved with deviations, investigations and change controls.
Implements and maintains all validated computer 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 validated computer systems
Conducts investigations into qualification failures, develops and implements remediation plans
Oversees vendors for qualification and metrology functions.
Initiates, guides and reviews written procedures for calibration and preventive maintenance of stand-alone computerized systems
Works with other validation engineers to develop scientific approaches for calibration, equipment qualification and validation techniques.
Initiates, manages and leads cross-functional/cross-site projects of small to medium scope and complexity.
Manages laboratory computer system implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
Provides expert guidance to internal customer groups in the procurement, operation, and compliance aspects of computerized systems to meet business needs in accordance with required schedules or dates.
Assists facilities with new construction and relocation projects which involve computerized systems.
Reviews all calibration, qualification and validation documentation for accuracy, completeness and compliance to 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, system validation, 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 Equipment Commissioning and Qualification 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
IMPORTANT - Strong knowledge of cGXP requirements and good documentation practices relating to computerized systems, equipment, and instrumentation within the pharmaceutical industry
FOCUS ON THIS ***Advanced knowledge of 21 CFR Part 11 compliance*** (candidates should be aware of this if they work in this field) and 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
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.
Preferred BS degree in Engineering, Biology, Chemistry, Computer Science, or equivalent
Preferred 5 years of experience in FDA-regulated GMP lab environment
Must have experience using or working with stand-alone computerized lab systems