Validation Associate - Abzena

Validation Associate

Location: San Diego, CA
Area: Technology Services

Overall Responsibilities:

  • 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.

 

General Responsibilities:

  • 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.

 

Qualifications/Skills Required:

  • 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.

 

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