Validation Engineer

Position Summary:

• Responsible for all aspects of the validation process, including: documenting commissioning activities; establishing the process and equipment acceptance criteria; and developing and performing qualification studies to document evidence which provides a high degree of assurance that equipment and processes (including cleaning processes) will consistently produce a product meeting its predetermined specifications and quality attributes. Work closely with all departments and be responsible for various projects.

Essential Duties & Responsibilities:

• Schedule and plan equipment and process qualification workload to meet approved schedules.
• Handle multiple projects and work independently.
• Write, execute, and review complex protocols.
• Coordinate validation activities with other departments.
• Operate Thermal Mapping Equipment
• Able to problem solve with little oversight, including conducting research to aid in the resolution of issues that arise.
• Train other Validation personnel.
• Purchase supplies and equipment for validation activities.
• Administer the site Change Control Program.

Education and Experience:

• Bachelor's Degree from a four-year accredited college or university with Major Chemistry, Engineering, Microbiology, or a related field.
• Minimum three years’ experience in the pharmaceutical industry, or equivalent experience.
• Demonstrate experience validating a wide range of equipment and processes (including cleaning processes), including mixing, sterile fill, freeze drying, parts washers, vial washers, dehydrogenation, wet steam and dry heat sterilization, and packaging.
• Demonstrate experience and knowledge of qualifying changes to validated systems/processes/and equipment.

Job Prerequisites:

• Ability to meet attendance standards.
• All full-time employees are required to work a 40-hour week.
• At times it may be necessary to work additional hours to get the required tasks accomplished to meet deadlines.
• Previous experience in the pharmaceutical industry with a manufacturing background.
• Advanced knowledge of cGMP's and regulatory requirements as they relate to IQ/OQ/PQ/VQ's.
• Physical Demands, Mental Requirements, and Work Environment:
• While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear.
• The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use.
• The noise level is usually quiet.
• Requires normal range of hearing and vision to record, prepare, and communicate appropriate reports. Requires exposure to machines, and occasionally chemicals and solvents. Requires moving of loaded carts into and out of equipment. Preparing loads of different weights and sizes to use for validation purposes.

Mental Requirements

• Ability to hear accurately the spoken word with moderate office noise or plant noise; Ability to apply deductive reasoning and understand complicated issues; Ability to receive instructions and follow work rules and company policies; Ability to follow safety and security practices; Ability to occasionally work off hours and weekends to meet deadlines; Ability to effectively deal with office stress; Ability to accurately communicate ideas, facts, and technical information; and Ability to maintain confidentiality of certain information.