Validation Associate (2nd Shift)

Job Title

Validation Associate

Job Description

PURPOSE:

To support validation of manufacturing and packaging processes, cleaning processes, and qualification of equipment.

 

GENERAL DESCRIPTION:

The Validation Associate supports the procedures for validation 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.

Participate in creating master validation plan.

Participate in creating validation policy.

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 Validation Manager.

Participate in customer and regulatory inspections.

Participate in employee training program.

Perform all other job duties as assigned by Humco 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.

 

PHYSICAL DEMANDS:

This position is approximately 80% clerical. Occasionally will require walking, bending, lifting (possibly up to 40 lbs. or more).  Specific vision abilities required by this job include close vision and color recognition.

 

ENVIRONMENTAL DEMANDS:

This position requires occasional working with hazardous and toxic chemicals, dust, and fumes necessitating use of personal protective equip­ment such as safety glasses, face shields, respirators, fume hoods, etc.

 

PERFORMANCE STANDARDS: 

Within 90 days of initial employment, the Validation Associate should be capable of performing duties as described with minimal assistance. Compliance within the guidelines of the company's Corrective Counseling Policy will be required.

 

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 HHG Employee Handbook

Additional Information

Status:  Exempt

Basic Qualifications