Job Information
Fareva Morton Grove Sr. Validation Engineer in Morton Grove, Illinois
This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/jobs/11869390
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POSITION DESCRIPTION
POSITION TITLE:
Senior Validation Engineer
POSITION GRADE
JOB CODE Exempt
REPORTS TO POSITION TITLE: Sr. Quality Manager
DATE LAST UPDATED August 2023
PEOPLE MANAGER (YES) (NO) No
POSITION SUMMARY
Summarize the primary purpose & key accountabilities of the position, including scope of responsibility in 5-7 concise
sentences. It may be helpful to complete this section after you have finished the other sections of the document.
This position is responsible for managing the Cleaning and sanatitization Program for the site. Position requires knowledge
of Cleaning and SanitizationValidation for OTC and cosmatics. The position requires to be the Subject Matter Expert in
the field of Cleaning and sanitization program and validation. Be able to support the facility and attest to cleaning during
internal and external audits. Position requires ability to problem solve, work on cross functional teams, mentor staff, work
with cross functional teams from batch processing, packaging and micro laboratory and work independently.
POSITION RESPONSIBILITIES
In order of importance, list the primary job areas of responsibility critical to the performance of the position. Identify
supporting activities demonstrative of expected behavior and activities. Indicate expected percentage of time for each area of
responsibility to a total maximum of 100%.
Responsibility Supporting Activities % of Time
Lead the Cleaning, sanitization &
Validation Program
? Plans, implents a robust cleaning and sanitization program by
authoring and leading the sanaitization Validation Program
for all products and product contact equipment.
? Leads the excuation of the cleaning and sanitization
validations by authoring protocls, hands on excuation of the
protocols and authoring the final report
? Ensures that deliverables are carried out in a timely and
compliant manner.
? Author or update SOPs to support the cleaning the
sanitization program.
? Lead the training for the processing and packaging personal
on the execuation of the cleaning and sanatizion SOPs
? Supports the Sr. Quality Manager during external and
regulatory audits.
? Leads the activities related to investigations for Micro OOSs,
initiates and follows-up on the implementation of corrective
actions
? Subject Matter Expert in the field of Cleaning and
santatization program & Validations
? Leads the personal Hygine program to ensure proper PPEs
for the site are appropriate for each area of the facility and
ensuring cGMPs are followed and adhered to.
60%
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General Activities ? Support the Cleaning & Sanatization processing and
packaging personal
? Reviews performances of Cleaning and Sanitization program
in regard to the achievement of goals, objectives and key
result areas.
20%
Support ? Designs, develops and evaluates plans for
projects/studies/investigations/reviews.
? Completely responsible for planning and execution of all
tasks needed to the execuation of the cleaning validations.
? Seeks advice on planning from management when there are
priority conflicts.
10%
SOPs and Administration ? Able to make independent contributions to the development
of new technologies, developing and revising methods and
procedures to assure compliance with applicable regulations;
carries out technical and administrative duties as assigned.
5%
Trains and Mentors ? Trains on new and existing procedures, techniques and
governmental regulations as directed by management.
5%
ORGANIZATIONAL RELATIONSHIPS
Provide the primary groups or key positions that this position will have interaction with as a regular part of the position
responsibilities. Include any external interactions as appropriate.
Quality Operations/Primary Processing Unit/Engineering & Mai