Location: San Diego, CA
- Direct validation activities in a cGMP manufacturing environment.
- Develop validation schedules.
- Develop validation/qualification documents for simple to complex manufacturing, laboratory and facilities equipment systems, including associated software.
- Execute simple to complex system validations/qualifications.
- Review simple to complex system validations/qualifications.
- Participate 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 to complex system evaluations and processing Equipment Change Requests.
- Critically review qualification-related records that are submitted by other in-house personnel or by outside vendors.
- Perform calibration and maintenance activities on validated systems. Resolve testing problems.
- Provide guidance to Equipment Owners that facilitates optimal equipment usage:
- Make recommendations to Equipment Owners during selection and maintenance of equipment, helping them to choose equipment that is best-suited for their needs
- Initiate and/or propose Equipment SOP development, recommending to the Equipment Owner 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.
- Troubleshoot system breakdowns.
- Oversee and provide leadership within the Validation department by mentoring and training less-experienced team members.
- 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.
- 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 subordinates.
- Ability to participate effectively as a team player in all aspects of Abzena’s business.
- Travels as needed to attend professional conferences, and train on new technologies.
- Associate’s or Bachelor’s Degree in a relevant engineering discipline, such as electrical, manufacturing, mechanical, and software engineering.
- With an Associate’s degree, a minimum of seven (7) years related experience required. With a Bachelor’s degree, 5-7 years of related experience is required.
- (Required) Knowledge and understanding of cleanroom operations, laboratory controls and safety.
- (Required) Ability to work in an FDA GXP regulated environment.
- (Required) Proficient 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.