Validation Engineer - seeking Luke or Leia

Validation Engineer - seeking Luke or Leia Full-time Company Description If you are looking for a well‑known company that takes a premium on the clientele then continue reading. We want to hear from high impact, low maintenance individuals that want to continue both personal and professional growth. Responsibilities The Validation Engineer III (VE‑III) reports to the Manager of Validation. The VE‑III will be responsible for performing validation in a GMP biotech manufacturing facility, managing medium‑sized validation projects and providing technical assistance to less experienced technicians/engineers. Responsibilities include the development of Validation Plans for small to large‑size validation projects, qualification and validation of equipment, facilities, utilities, as well as cleaning, sterilization, and manufacturing processes. The successful candidate will be responsible for developing complex protocols using a risk‑based approach that meets current regulatory requirements and industry practices, as well as performing Design Qualification. The VE‑III will also be responsible for reviewing and approving peer validation reports and presenting the validation approach and study results to peers and managers. Qualifications Engineering/science bachelor’s degree with minimum 10+ years of industry experience (7 years validation). Working knowledge of GMPs. Experience with validation using a risk‑based approach (FMEA, PHA, etc). Development of project execution plans for medium to large size projects. Strong experience directing and supervising project execution for medium to large size projects. Strong experience troubleshooting, investigating, and effectively managing deviations and discrepancies on project execution for medium to large size projects. Working knowledge of ICH Q8, Q9, Q10 and other international regulatory requirements. Excellent technical writing and verbal communication skills. Ability to read/interprete engineering drawings and design documents. Development of project execution plan and management of small to large size projects. Knowledge of Validation Lifecycle Approach (e.g., ASTM E2500). Conducting statistical analysis of validation test results. Proficient in use of GE/Kaye Validator 2000. Must be people‑oriented and a team player. Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Visio. All your information will be kept confidential according to EEO guidelines. #J-18808-Ljbffr