|• Applies existing validation programs for the commissioning and qualification of new equipment, instruments, including major capital projects and computer systems
• Maintains validation programs for existing equipment, utility commissioning and qualification, and computer systems
• Drafts, reviews, and executes protocols and reports related to equipment, facility, method, computer, and process validation. This includes deviation reporting during execution
• Acts as a quality contact for Validation, including Computer System Validation (CSV) and Quality Risk Management
• Ensures that the site Validation Master Plan remains current and aligned with corporate policies
• Provides statistical support for Quality Systems monitoring and review
• Reviews and approves changes to critical processes, facilities, equipment and systems through the change control program to ensure impact on validated systems
• Assists in customer / regulatory audits and responding to audit observations and corrective actions
• Bachelor's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science; or
• Associate’s Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of two years’ related experience.
• Ability to use Excel, Word, and other office systems.
• Ability to apply regulatory authority and guidelines with training.
• Maintain high quality documentation in accordance with applicable regulatory guidance and Site SOPs.
• Ability to learn and use quality management software (e.g. TrackWise®, ComplianceWire®).
• Ability to learn and retain technical information.
• Basic understanding of pharmaceutical laboratory and / or production operations.
• Ability to complete investigation, deviation, and change control forms with initial consultation from supervisor as needed
• Edits Standard Operating Procedures (SOPs), Protocols, and reports independently and accurately.
• Ability to problem solve to initiate and execute/monitor corrective action.
• Ability to independently interpret data, analyze trends and provide insight into potential issues and subsequent solutions.
• Ability to see and hear, read and write clear English.
• Requires adaptability, analyzing, assessing, calculating, decision making, dependability, good judgment, reading, memorizing, social skills, speaking, stress control, writing.
• Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, in a professional and accurate manner.
• Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time.
• Ability to cooperate with coworkers within an organized team environment or work alone.
• Detail oriented and well organized with ability to work effectively under high pressure with multiple deadlines.
• Ability to put aside personal opinions and focus on business needs, department needs or group needs.
• Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening.
• Occasional stooping, kneeling, crouching, bending, carrying, grasping.
• Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds.
|Start Time:||12:00 AM|
|Hours:||8:00am to 5:00pm|
|Additional Job Details:||GMP experience and experience with good document practice is strongly preferred. Role will focus on reviewing validation protocols to test new equipment before moving to production floor.|