Primary Function/ Primary Goals/ Objectives:

　　Ensure that change control and validation activities are executed in a timely manner.Major Responsibilities:

　　Comply to all policies and standards.

　　Develop, execute and review validation protocols and related documentation in accordance with Abbott procedures and policies.

　　Lead Failure Mode Effects Analysis (FMEA) for new equipment installations or changes.

　　Manages site Validation Review processes (VRB), review and approve site change controls (plant and laboratories related) and validation change requests.

　　Perform root cause analysis and identify corrective and preventive actions in addressing quality events

　　Support resolution of validation events and escalate concerns in a timely manner.

　　Support in equipment and process walkdowns

　　Weekly, Monthly and Quarterly reporting as required for own business area

　　Support Monthly and Quarterly Quality Management Review (QMR) and Business Management Review (BMR)

　　Coordinate and support periodic plant stoppage activities related to validation and change control functions

　　Develop and execute business area improvement projects

　　Participate in internal and external audits

　　Participate in division and site projects, improvement activities and technical sharing platforms

　　Any other ad-hoc requests as assigned by the supervisor.

　　Skills/Experience Requirements:

　　Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) in a food or pharmaceutical manufacturing industry.

　　Familiarity in developing SOPs and work flows

　　Knowledge of problem-solving tools (e.g. 6M Analysis, Fishbone, 5 Whys, etc.).

　　Familiarity with international and technical standards is a plus (ISO, FSSC etc)

　　Proficient in Microsoft applications (Powerpoint, Word, Excel)

　　Team player with initiative, drive, good communication skills and a strong command of written English

　　Ability to do data analysis using Minitab, JMP is a plus.

　　Experience in manufacturing process design and equipment design or application is a plus.

　　Proven problem-solving capability, customer focus and commitment to continuous improvement.

　　Education:

　　Degree in a Science or Engineering discipline.

　　Diploma in a Science or Engineering discipline with minimum 3 years working experience.

　　An Equal Opportunity Employer

　　Abbot welcomes and encourages diversity in our workforce.

　　We provide reasonable accommodation to qualified individuals with disabilities.

　　To request accommodation, please call 224-667-4913 or email [email protected]