Validation Engineer - Abzena

Validation Engineer

Location: San Diego, CA
Area:

Typical Duties:

  • 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.

 

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 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.

 

Qualifications/Skills Required:

  • 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.
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