Computer Software Validation Engineer
Location: San Diego, CA
Area: Technology Services
- Author and/or maintain Computer Software Validation Master Plans.
- Independently develop validation/qualification documents for computerized systems.
- Execute computerized system validations/qualifications, as needed.
- Independently review computerized system validation/qualification documents that are submitted by other in-house personnel or by outside vendors .
- Lead cross-functional teams to establish system requirements and to apply risk management techniques to computerized systems.
- Plan validation activities and coordinate project timelines to ensure timely and thorough completion of all validation deliverables.
- Support the system validation lifecycle by performing routine system evaluations and processing Change Requests.
- Interface directly with outside service providers and provide objective/critical assessments of their work.
- Mentor and train less-senior validation staff and staff from other departments on the technical aspects of validation and Good Automated Manufacturing Practices.
- Independently author system administration procedures for managing computerized systems.
- Provide guidance to Equipment Owners that facilitates optimal computerized system usage:
- Ensure appropriate measures are in place to maintain data integrity within their systems.
- Assist with software selection, design, configuration, implementation and administration.
- Utilize computerized system expertise to effectively troubleshoot system breakdowns, as needed.
- Adhere to Good Manufacturing Practices (GMPs), including adherence to all company SOPs and documentation standards.
- Maintain clear, concise, and compliant records of all work performed.
- Perform other related duties as assigned.
- Operates to the highest ethical and moral standards.
- Complies with Abzena’s policies and procedures.
- Adheres to quality standards set by regulations and Abzena policies, procedures and mission.
- Communicates effectively with supervisors, colleagues, and staff.
- Ability to participate effectively as a team player in all aspects of Abzena’s business.
- Travels as needed between sites and to attend professional conferences and train on new technologies.
- Advanced degree with five (5) or more years of related experience, Bachelor’s degree with eight (8) or more years of related experience, or Associate’s degree with ten (10) or more years of related experience.
- (Required) Knowledge and understanding of cleanroom operations, laboratory controls and safety.
- (Required) Ability to work in an FDA GXP regulated environment.
- (Required) Competent skills using Excel, Word, and PowerPoint programs.
- (Preferred) Ability to operate, calibrate, qualify, and maintain laboratory and manufacturing equipment.
- (Required) Skill through experience validating computerized equipment systems utilizing GAMP principles.
- (Required) Skill through experience with computer systems such as BMS and Asset Management software.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and governmental regulations.
- Ability to write reports, business correspondence, and procedures.
- Ability to effectively present information and respond to questions from staff and groups of managers.
- Ability to develop and maintain effective working relationships with all levels of management.
- Ability to work with mathematical concepts such as probability and statistical inference.
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where general standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Ability to understand and comply with all applicable laboratory regulated guidelines.