Validation Associate

PURPOSE:

The Validation Associate is responsible for supporting validation of manufacturing and packaging processes, cleaning processes, and qualification of equipment. This person will also be responsible for the generation of Annual Product Reports. This person will also be responsible for facilitating internal deviation and investigation reports.

GENERAL DESCRIPTION:

The Validation Associate supports the procedures for validations in an FDA regulated environment

JOB FUNCTIONS:

• Perform annual product reviews (APRs) of manufactured drug products.
• Draft validation protocols for process, cleaning, equipment, and computer systems as needed.
• Perform batch record review of manufactured product for release.
• Conduct special projects as directed by the Validation Manager.
• Revise and author SOPs as needed.
• Revise batch records as needed.
• Participate in the effective use of quality systems.
• Collaborate with QC labs on method validations and qualification of lab equipment.
• Perform any additional projects/tasks assigned by Quality Manager.
• Participate in customer and regulatory inspections.
• Participate in employee training program.
• Perform all other job duties as assigned by Pharma Nobis management.

QUALIFICATIONS:

• Must be safety minded.
• Excellent organization and computer use skills (MS. Word, MS Excel).
• Must be able to follow instructions and procedures.
• Must be able to interpret analytical data.
• Must be scientific and safety minded.

EDUCATION REQUIREMENTS:

• A bachelor’s degree is strongly preferred with emphasis in Math, Engineering, Biology, Chemistry, or Physics.
• Experience as a validation engineer or previous experience in validation preferred.
• Strong written and verbal communication
• Excellent attention to detail

PHYSICAL DEMANDS:

This position requires sitting, standing, walking, reaching, stooping, and the use of both hands along with lifting up to 40 pounds while bending and twisting of the upper body. Specific vision abilities include the use of continual reading from a computer monitor for long periods of time.

ENVIRONMENTAL DEMANDS:

This position requires working for long extended periods of time with a computer screen and keyboard. Occasionally, the job involves working around elevated noise levels. These levels are not damaging, but can be uncomfortable at times. As a result, Pharma Nobis does make earplugs available for use by all employees. The job may also involve working around machinery with exposed moving parts, which can pose a mechanical hazard if proper operating procedures are not followed. Also, in a typical workday, the job may involve working around forms of dust and chemical hazards. If a project requires actual contact with any product, Safety Data Sheet information provides instruction about the personal protective equipment (PPE) that must be worn.

PERFORMANCE STANDARDS:

This job must be performed with a low level of supervision, and/or direction from the Quality Manager in a way which will ensure a safe and quality finished good product in conjunction with complete compliance with Pharma Nobis cGMP process. Good job performance will include the initiative to do work and solve routine problems before being so directed, and to consult with management or other applicable resources as necessary.

The position may require evening and/or weekend work on short notice.

Duties must always be conducted in a professional manner, and all personnel must be treated with courtesy and respect. A positive attitude with a willingness to embrace new challenges is key. Punctuality and attendance is required subject to Pharma Nobis Attendance & Tardy policies, in conjunction with corrective counseling (up to and including termination).

BEHAVIORAL SKILLS:

• Ability to follow instructions and procedures in a timely and safe manner.
• Ability to interact with supervisors, co-workers, in a courteous and professional manner. Ability to retain confidential information as confidential.
• All employees will follow and uphold policies as set out and signed in Pharma Nobis Employee Handbook

Basic Qualifications

• Techincal writing experience
• Excellent computer skills (including experience with MS Offce)