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Capstone, Inc.

Responsibilities:

  • Develop validation/qualification documents for moderately complex to complex manufacturing, laboratory and facilities equipment systems, including any associated software.
  • Execute moderately complex to complex system validations/qualifications.
  • Review moderately complex to complex system validations/qualifications 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 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.
  • Participate in equipment planning and facility design activities, as needed.
  • Mentor and train less-senior validation staff and staff from other departments on the technical aspects of validation and Good Manufacturing Practices.
  • Provide guidance to Equipment Owners that facilitates optimal equipment usage: o 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.

Qualifications/Skills Required:

  • Bachelor's degree with five (5) or more years of related experience, or Associate's degree with seven (7) or more years of related experience.
  • Minimum 5 years directly related experience
  • Knowledge and understanding of cleanroom operations, laboratory controls and safety.
  • Ability to work in an FDA GXP regulated environment.
  • Competent skills using Excel, Word, and PowerPoint programs.
  • Ability to operate, calibrate, qualify, and maintain laboratory and manufacturing equipment.
  • Skill through experience validating computerized equipment systems utilizing GAMP principles.
  • 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.