Validation Specialist III

Job Title: Validation Specialist III

Location: Framingham, MA

Duration: 8 Months (Possible Extension)

Job Responsibilities:

• Perform validation (IQ, OQ, PQ) of various types of equipment and systems including validation or requalification of temperature controlled chambers and lab equipment.

• This would include refrigerators, cold rooms, freezers, incubators, liquid N2, etc.

• Write and execute validation protocols and write validation reports including thorough resolution of protocol deviations or non-conformances.

• Investigate/troubleshoot validation problems or issues; conduct statistical analysis of testing results.

• Perform 21 CFR Part 11 and EU Annex 11 gap assessment on existing scientific application software that is being used in laboratories. Develop 21 CFR Part 11 and EU Annex 11 compliance plan.

• Assess compatibility of instrument software with existing windows operating system.

• Collaborate with instrument software vendors to execute 21 CFR Part 11 and EU Annex 11 compliance plan including preparation of user requirement specifications (URS) and functional specifications, GxP impact assessment, risk assessment and validation (IQ/OQ/PQ).

• Receive instructions on related assignments under general supervision.

• The position will report to Manager, Quality Process Analysis with a dotted line to the Manager, R&D Validation.

Qualification:

• Experience or familiarity with applicable US and worldwide regulatory requirements for the biotechnology industry (EU Annex 11, 21CFR Part 11, etc.).

• Demonstrated knowledge of GMP regulations and good documentation practices is required.

• Familiarity with application software such as Waters MassLynx, Beckman-Coulter 32 Karat, Applied Biosystems 7500 SDS, Molecular Devices Softmax Pro, Gage InSite, TrackWise, etc.

• Proficiency with MS Word, MS Excel, MS Access, MS PowerPoint, MS Project.

• Experience with Microsoft Word, Excel, Project, and Visio.

All your information will be kept confidential according to EEO guidelines.