Validation Technician
- Contract
Company Description
SPECTRAFORCE TECHNOLOGIES INC (www.spectraforce.com) is a leading Global Staffing and IT services company. At Spectraforce, we truly believe and practice in our core values and entrepreneurial work culture – attributes which make us unique in our industry. Spectraforce is one of the Top 10 fastest growing staffing companies in the nation, as listed by SIA or the past two years. Our success comes from our employees and our “partner for life” ethos, which has translated into a highly satisfied client base. Spectraforce offers staffing services to Fortune 500 clients broadly in the following areas: IT, Clinical, Scientific, Finance, Professional and Engineering.
Job Description
- The Validation Technician will work to support site validation and technical transfer experts on specific project teams. He or She will participate in the development and execution of test plans for manufacturing and packaging equipment and processes, utilities, and facilities to support the Validation and Technical Transfer functions.
The incumbent will actively collaborate with multiple functions within project / product teams to:
- Prepare, review, execute, and summarize validation protocols (IQ, OQ, PQ, PV and/or CV) for aseptic pharmaceutical manufacturing
- Prepare equipment, processes, product, and cleaning procedures
- Document validation plans and protocols (tests) to provide objective evidence that equipment, processes, and product meet requirements and are compliant with applicable regulations
- Conduct validation testing for new products and process improvements
- Interact with individuals from different disciplines (Engineering, Laboratory, Operations, and Quality) to plan, execute, and complete validation activities
- Ensure validation efforts are conducted in an appropriate and timely manner
- Perform risk assessment exercises in support of validation activities
- Prepare Technical Packages and assessments for product transfers
- Other duties as assigned by area management
Qualifications
- Minimum 5 years pharmaceutical/medical device manufacturing, validation or related experience OR Associate degree in related field such as science, engineering, or manufacturing technology and 3 years pharmaceutical/medical device experience, OR Bachelor degree in related field such as science, engineering, or manufacturing technology and 1 year pharmaceutical/medical device experience .
- Strong interpersonal and project management skills; must be able to interact effectively at all levels of the company and handle confidential and sensitive information appropriately.
- Ability to work both independently and in partnership with others.
- Expertise in Microsoft Office applications, including Word and Excel, and data entry experience.
- Must be able to work multiple shifts as needed to meet deadlines.
Additional Information
Regards,
Amit Sharma
Client delivery lead
Spectraforce Technologies Inc.
919-887-6786 ext.4052
Fax No.# 919-573-9398
Email: [email protected]
Visit us: http://www.spectraforce.com
Linkedin: http://in.linkedin.com/pub/amit-sharma/41/86/7a1
"Be the change you want to see in the world."