R&D Senior Quality Specialist (Validation),
R&D Senior Quality Specialist (Validation),
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Key Responsibilities
- Support the qualification and requalification of equipment and instrumentation including computerized systems used within the R&D laboratory function associated with FDA Good Manufacturing Practices (GMP) testing for biological and small molecule projects.
- Responsible for the planning design and implementation of validation projects coordination of validation activities and preparation of validation documentation within Pharmaceutical Development with established guidelines for pharmaceutical products manufactured in a GMP environment.
- Utilize knowledge of GMP concepts relating to Pharmaceutical manufacturing environment to plan develop organize and execute validation activities applicable to area of technical expertise in accordance with GMP ISO 9000 ICH and applicable guidelines including project management validation documentation generation and project tracking.
- Maintain project deadlines and communicate validation activities with appropriate personnel in a timely manner.
- Define author organize and review validation documentation SOPs and forms.
Qualifications :
Education & Experience
Must possess a Bachelors in Engineering Microbiology or Chemistry or a related field and at least 5 years of work experience performing GMP validation. Of experience required must have 3 years of work experience:
- Performing laboratory instrumentation validation temperature mapping of environmental chambers & sterilization validation (autoclaves);
- Project coordination involving third-party validation vendor management;
- Utilizing validation principles and techniques including validation of pharmaceutical processes facilities/utilities manufacturing & laboratory equipment; &
- Applying GMP concepts relating to pharmaceutical manufacturing environment & validation activities.
Experience must be gained concurrently.
Additional Information :
Salary Range: $124920.26 - $157500.00 per year
Apply online at or send resume to .. Refer to Req ID: REF35111G.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term and long-term incentive programs.
AbbVie is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
