Assesses client computer systems and identify any potential Part 11 or Annex 11 gaps to ensure data integrity best practices are enforced.
Provide subject matter expertise in project teams executing various validation projects ensuring that project deliverables are compliant with all applicable regulations including FDA's GLP, GCP and GMP/Part 11 and EU Annex 11 and industry guidelines like ISPE GAMP5.
Conduct gap assessment and provide resolution to mitigate all findings.
Generate/Revise/Execute system life cycle deliverables including SOPs (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report).
Execute Commissioning, Installation, Operation and Performance Qualification Protocols for various life science lab, computer systems, manufacturing and packaging equipment and utilities.
Review off the shelf software, software development tools and software systems used in quality processes to determine appropriate validation requirements.
Provide routine progress and issue updates to the project team.
Participate in client Validation teams in executing routine Validation deliverables in a staff augmentation role.
Education & Experience:
Bachelor's degree in chemical, biomedical or biochemical engineering, biological sciences, or related field/experience.
8+ years relevant industry experience pharmaceutical, biotechnology and/or medical device manufacturing equipment, automation, processes and facilities for CSV Engineer/Specialist I.
Demonstrated knowledge of cGMP manufacturing as well as regulatory regulations and requirements for biotechnology, pharmaceuticals and medical devices with an emphasis on 21 CFR Part 11, Annex 11, Data Integrity, and GAMP5.
Possesses a thorough understanding of Data Integrity Concepts and ALCOA Principles.
Demonstrated knowledge of the development of protocols for the Validation of complex computer systems (e.g., multiple GAMP classes of systems).
Strong experience with FactoryTalk, Electronic Lab Notebook (ELN), Laboratory Systems Background (LIMS) and Laboratory Equipment (HPLC, GC, AA) Oracle, Track wise, and CMMS.
Ability to think critically and demonstrate troubleshooting and problem-solving skills.
Able to function efficiently and independently in a fast-paced, changing environment.
Able to lead and contribute as part of a team.
Possess excellent interpersonal, verbal, and written communication skills
Understanding of automated systems including Emerson Delta V, Rockwell Automation, Wonderware, and Client.
Understanding of quality systems such as change control and discrepancy investigations.