Validation Engineer II
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Position is responsible for but not limited to, working under Global Pharm Technology department in developing and implementing product, process, and equipment, and validation protocols, as applicable to ensure compliance to applicable regulatory requirements, internal company standards and industry practices. As a member of Operation/Validation team, responsible for developing /supporting of revenue and process improvement projects and executing IQ/OQ/PQ/PV protocols and making recommendations for changes and/or improvements. Ensure project completion per schedule, overall compliance and continuous quality and product/process improvement in an ever-changing, regulated environment. KEY DUTIES AND RESPONSIBILITIES: Describe scope: % of Time or Importance
Develop / write validation documents such as URS, IQ/OQ/PQ/PV, etc. and specifications for equipment, HVAC systems, products and processes, including executing validation protocols, writing validation plans and final validation reports.
Manage / perform change control by Processing Equipment Work Request (EWR) and Equipment Installation Request, evaluate validation requirements after equipment repairs, develop / write and execute validation test scripts/protocols for equipment, systems, products and processes, including required annual re-qualifications and writing validation plans and final validation reports, as applicable.
Perform Non-conformance (NCR) Investigation, Corrective and Preventative actions (CAPA), and effectiveness check (EC) and collaborating with quality, manufacturing and other stake holders in the root cause verification and corrective action implementation including validation, as required.
Develop and / or revise manufacturing and specification documentation, validation protocols, SOPs, etc. including technical writing for Quality, Equipment and Processing Operating Procedures (SOP), Component Specifications and other documentation with ensuring compliance between manufacturing process documentation and training requirements.
Lead and effectively interface with manufacturing, production, quality, sales, marketing, external vendors, and other support teams to complete projects to meet production, quality, cost savings, and new product / process development goals within schedule and budget.
Develop and perform engineering studies for improvement of equipment performance or process capabilities to reduce costs and cycles with ensuring validations.
- Specific experience in IQ/OQ/PQ/PV Protocol development and execution for equipment / process / system such as autoclave, freeze dryers, sealers, freezers, refrigerators, HVAC System, etc. Experience in Temperature Mapping using Kaye validator & Val-probe system, RO Water and HVAC System qualification is preferred.
Education and Experience
- BS in Mechanical, Chemical, or Material, Physical / Technical Engineering (or other sciences)
- Preferred MS in Mechanical, Chemical, or Material, Physical / Technical Engineering (or other Engineering/Sciences)
- Minimum 3– 4 years in Technical/engineering, validation experience
- Demonstrated understanding and use of statistical methods in experiment design, data analysis, validation, and process monitoring is preferred
- Experience in Manufacturing and Industrial engineering in a FDA regulated field and familiarity with lean manufacturing methods a plus
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
- Proficiency in Microsoft office tools (excel, word, power point, Access, Project)
- Grasps concepts quickly especially related to Federal, AATB, ISO and other regulatory guidelines including understanding of the various regulations and guidelines such as FDA 21 CFR 1270 and 820, ISO 13485 and others as required
- Self-starter with excellent technical writing, analytical and interpersonal skills to allow effective participation in project teams and technical writing skills
Significant Work Activities
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.