Validation Engineer (III)

Job Description

DO WORK THAT MATTERS

At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.

Abbott Rapid Diagnostics (formerly Alere) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

RESPONSIBILITIES:

Successful candidate will assist in the development of assembly and packaging validation protocols, performs testing and write validation reports for various equipment and methods. Generate validation protocols using templates. Primary responsible for protocol execution of various types of basic processing equipment under the direction of site management. Additional responsibilities may also include equipment calibration, maintenance, and troubleshooting.

Knowledge Skills & Abilities:

• Perform activities pertinent to Toxicology testing, method and equipment start-up testing, and execution of qualification and validation protocols.
• Author validation documentation including, but not limited to, Installation, Operational and Performance Qualification protocols and reports, Process Validation protocols and reports, and Protocol Discrepancies and Addenda; IQ/OQ/PQ
• Prepare Equipment and Process validation protocols according to internal and external requirements.
• Execute qualification and process validation tests in accordance with approved protocols, procedures and guidelines.
• Analyze validation test data to determine systems have met validation criteria.
• Write validation final reports that offer conclusions based on test results.
• Document testing results in validation/qualification protocols per protocol requirements; obtain samples to be analyzed per qualification/validation protocol requirements.
• Assure that all validation activities are performed in compliance with approved validation/qualification protocols, standard operating procedures (SOPs), and current regulatory requirements/guidelines.
• Has proficiency in more than one functional area (Equipment Qualification, Process validation, etc.)
• Keeps current on regulatory and quality requirements for regulated testing, qualification, data integrity and validation activities.

MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:

• Bachelor’s degree in Engineering or Science discipline
• 3 years working knowledge of analytical testing industry; solid phase and liquid/liquid extraction methods; GC/MS, GC Headspace and LC-MS/MS methodologies.
• Minimum 3 years of industry experience in Biotech, Pharmaceutical, Medical Device Design, Chemical, Validation, or QA.
• Experience in writing and execution of IQ, OQ, and PQ forms and protocols for Equipment, Systems, and Software.
• Experience in Validation with knowledge and understanding of toxicology regulatory requirements
• Experience with Process, Computer System, Methods, and other validation activities and processes

PREFERRED QUALIFICATIONS:

• Experience with Risk-Based Approach to Commissioning and Qualification is beneficial
• Excellent communication skills, multi-task and able to work in a fast-paced environment
• Able to work extended hours on evenings and weekends as required
• Capable of detailed record keeping and communicating results to others
• Must be able to lift up to 20 pounds on a regular basis
• Must be able to wear personal protection equipment which includes gloves when required.

COMPETENCIES:

• Drives for results
• High level of attention to detail
• Teamwork
• Communication
• Strong organizational skills
• Initiative

About Abbott

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 130 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 107,000 of us are working to help people live not just longer, but better, in the more than 160 countries we serve.

AN EQUAL OPPORTUNITY EMPLOYER, ABBOTT WELCOMES AND ENCOURAGES DIVERSITY IN OUR WORKFORCE.

We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please send an email to [email protected].