- Responsible for creation, planning & approval of validation documents to support validation requirements.
- Responsible for participating in implementation & maintenance of effectiveness of the Quality system to meet applicable regulatory requirements.
- Adhere to Good Manufacturing Practices (GMPs), ISO:13485, ISO:14971, & 21 CFR 820.
- Ensure that practices & procedures comply with company policies & applicable regulations for the Quality areas.
- Execute tasks as required to implement Validation Master Plan & maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing process to demonstrate that products will perform consistently as intended.
- Supervise contract validation resources in the timely completion of activities in his/her area of responsibility.
- Represent department in quality audits, both internal and external, regarding validation & engineering compliance.
- Perform Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), & Process Performance Qualification (PPQ).
- Participate in implementation & maintenance of effectiveness of Quality System to meet all applicable regulatory requirements.
- Ensure that all practices & procedures comply with company policies & applicable regulations for the Quality areas.
- Document control of nonconforming products & implementation of corrective & preventative actions (CAPA) to address identified root causes compliant with ISO:13485 standards & 21 CFR
- Execute process monitoring plans based on quantifiable production & quality metrics.
- Participate with plant & external engineering resources on new installations & systems to ensure that factory, site, & commissioning documentation is in accordance with current Good Manufacturing Practices (cGMP) & supports validation.
- Good Manufacturing Practices (GMPs), ISO:13485, ISO:14971, & 21 CFR 820;
- Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), & Process Performance Qualification (PPQ);
- documenting control of nonconforming products & implementation of corrective & preventative actions (CAPA) to address identified root causes compliant with ISO:13485 standards & 21 CFR 820.90; &
- executing process monitoring plans based on quantifiable production & quality metrics.
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Validation Engineer - North Chicago, United States - AbbVie
Description
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us Follow @abbvie onX,Facebook,Instagram,YouTubeandLinkedIn.
Job DescriptionKey Responsibilities
Must possess a Bachelors degree or foreign academic equivalent in Biology, Chemistry, Biomedical Engineering, Mechanical Engineering or related scientific or engineering field plus an academic or industrial background in:
Apply online at Refer to Req ID: REF23813S.
Additional Information
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.
