Validation Engineer

Validation Engineer

Only candidate with minimum of 3 years pharmaceutical industry.

Reports To: Work Location: Decatur, Illinois, USA

Employer is able to sponsor TN visa for Canadian candidate willing to move to US.

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 fairly 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.

Disclaimer:

The list under Essential Functions and Additional Responsibilities is not exhaustive, but merely the most accurate list for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change. This position description in no way states or implies that the responsibilities and tasks are the only responsibilities and tasks to be performed by the employee occupying this position. She/He will be required to follow any other instructions and to perform any other job-related duties as required by his/her supervisor/manager. Requirements stated are minimum levels of knowledge, skills and/or abilities to qualify for this position. To perform the duties and responsibilities of this position successfully, employee will possess the abilities and aptitudes to perform each task proficiently. Employment decisions, including promotions, transfers and others, are based on meeting all requirements and on organizational needs, the employee being in good standing (including lack of disciplinary actions), meeting all applicable performance standards and other non-discriminatory criteria. The methods of fulfilling requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. THIS DOCUMENT DOES NOT CREATE AN EMPLOYMENT CONTRACT, IMPLIED OR OTHERWISE. WE MAINTAIN AN "AT WILL" EMPLOYMENT.

Job Type: Full-time

Pay: Up to $75,000.00 per year

Schedule:

• 8 hour shift

Experience:

• Sterile injectable: 3 years (Preferred)
• Pharmaceutical industry: 3 years (Preferred)
• cGMP requirements: 3 years (Preferred)
• ears of Validation Managerial: 3 years (Preferred)

License/Certification:

• Certified Quality Engineer (Preferred)

Ability to Relocate:

• Decatur, IL: Relocate before starting work (Preferred)

Work Location: In person