Carda Life Sciences
Validation Engineer - seeking Luke or Leia
Carda Life Sciences, Boston, Massachusetts, us, 02298
Validation Engineer - seeking Luke or Leia
Full-time
Company Description
If you are looking for a well knowncompany 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.
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 size 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.
Required Experience
Engineering/science bachelor’s degree with minimum of 10+ years of experience in the industry (7 years validation)
Preferred Experience
Working knowledge of GMPs
Validation using risk based approach (FMEA, PHA, etc)
Development of project execution plans for medium to large size projects
Strong experience with directing and supervising project execution for medium to large size projects
Strong experience with 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/interpret 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
We look forward to receiving your application! All your information will be kept confidential according to EEO guidelines. For confidential consideration please email your resume to Shawn.Schantz@genzyme.com
#J-18808-Ljbffr
Full-time
Company Description
If you are looking for a well knowncompany 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.
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 size 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.
Required Experience
Engineering/science bachelor’s degree with minimum of 10+ years of experience in the industry (7 years validation)
Preferred Experience
Working knowledge of GMPs
Validation using risk based approach (FMEA, PHA, etc)
Development of project execution plans for medium to large size projects
Strong experience with directing and supervising project execution for medium to large size projects
Strong experience with 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/interpret 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
We look forward to receiving your application! All your information will be kept confidential according to EEO guidelines. For confidential consideration please email your resume to Shawn.Schantz@genzyme.com
#J-18808-Ljbffr