Location: San Diego, CA
Area: Technology Services
- Develop validation/qualification documents for simple to complex manufacturing, laboratory and facilities equipment systems, including any associated software.
- Execute simple to complex system validations/qualifications.
- Review simple to complex system validations/qualifications submitted by other in-house personnel or by outside vendors.
- Participate in, and potentially take a lead role in, cross-functional teams to establish system requirements and to apply risk management techniques to equipment qualification/validation.
- 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 Equipment Change Requests.
- Interface directly with outside service providers and provide objective/critical assessments of their work.
- When applicable, perform calibration and maintenance activities on validated systems.
- Mentor and train less-senior validation staff and staff from other departments on the technical aspects of validation.
- Provide guidance to Equipment Owners that facilitates optimal equipment usage:
- Assist Equipment Owners during selection and maintenance of equipment, helping them to choose equipment that is best-suited for their needs
- Take an active role during Equipment SOP development, helping the Equipment Owner to establish appropriate preventive maintenance practices designed to maintain a qualified/validated state and reduce equipment downtime
- Install equipment in accordance with Manufacturer’s instructions, as needed.
- Utilize equipment 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.
- Bachelor’s degree with three (3) or more years of related experience, or Associate’s degree with five (5) 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.
- (Required) Ability to operate, calibrate, qualify, and maintain laboratory and manufacturing equipment.
- (Preferred) Skill through experience validating computerized equipment systems utilizing GAMP principles.
- (Preferred) 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.