Position Title: Quality Engineer
Position Number: 277234
Location: Round Lake, IL
Desired Skill Set:
FDA, Laboratory, Validation
Contract Start: 02/19/2018
Duration or End Date: 02/18/2019
This is a data integrity project on analytic instruments used in pharm and medical devices.
? FDA regulated environment. 21 Code of Federal Regulation (CFR)
? Looking for one candidate that is strong on the technical side (large computer system validation) and one that has strong validation experience on the engineering / scientific lab.
? Analytical Instrument examples include: HPLC, microscopes, tension machines, etc.
? Must have recent validation and laboratory experience..
?Supporting system owners with the generation and management of documentation associated with Medical Products instrument validation and qualification activities.
? Activity focus on laboratory equipment and instrument systems (LE&IS) utilized in the engineering, chemistry, and information technology areas.
? All activities will be performed in compliance with internal Baxter Quality System procedures and international/national regulations.
Essential Duties and Responsibilities
?Applies knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
? Serves as project lead with projects of intermediate scope and cross-functional teams.
? Incumbent will be responsible for the management and archiving of approved package documents.
? Incumbent may be involved with supporting system change control requests
? Mentors and provides leadership to junior team members.
? Handles routine tasks timely, accurately
Basic Knowledge about industry GMP/GDP
? Expertise with Instrument/Equipment validations
? Proficient in MS Word and Excel, Computer software
? Well organized & able to multi-task
? Team oriented
? Analytical mindset
? Able to summarize and easily explain complex situations
? Solid verbal and written communication skills, including technical/business writing
? BS in relevant Engineering/Science field. Otherdegrees acceptable with 3-5years of relevant and recent validation/qualificationexperience.
?Experience: 3 yrs in GMP-regulated industry, preferably medical device or pharmaceutical, 2+ years?experience performing instrument validations.
Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, arrest and conviction records, or any other characteristic protected by law. Positions located in San Francisco, California will be administered in accordance with the Fair Chance Ordinance.