Senior Quality Validation Engineer

2 weeks ago

Morton Grove, United States Katalyst HealthCares & Life Sciences Full time

Responsibilities:

Plans, implements a robust cleaning and sanitization program by authoring and leading the sanitization Validation Program for all products and product contact equipment.

Leads the execution of the cleaning and sanitization validations by authoring protocols, hands on execution of the protocols and authoring the final report

Ensures that deliverables are carried out in a timely and compliant manner.

Author or update SOP's to support the cleaning the sanitization program.

Lead the training for the processing and packaging personal on the execution of the cleaning and sanitation SOP's

Supports the Sr. Quality Manager during external and regulatory audits.

Leads the activities related to investigations for Micro OOS's, initiates and follows-up on the implementation of corrective actions

Subject Matter Expert in the field of Cleaning and sensitization program & Validations

Leads the personal Hygiene program to ensure proper PPE's for the site are appropriate for each area of the facility and ensuring cGMP's are followed and adhered to.

Support the Cleaning & Sanitization processing and packaging personal

Reviews performances of Cleaning and Sanitization program in regard to the achievement of goals, objectives and key result areas.

Designs, develops and evaluates plans for projects/studies/investigations/reviews.

Completely responsible for planning and execution of all tasks needed to the execution of the cleaning validations.

Seeks advice on planning from management when there are priority conflicts.

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.

Trains on new and existing procedures, techniques and governmental regulations as directed by management.

Requirements:

BS degree in Biology, Chemistry, Microbiology, Biochemistry or relevant science discipline

8 years of relevant Quality experience preferably in the pharmaceutical industry.

MS degree in Biology, Chemistry, Microbiology, Biochemistry or relevant science discipline 6 years of relevant Quality experience preferably in the /pharmaceutical industry.

Strong background in Cleaning and sanitization program and validations

Mentor/trains in routine procedures demonstrating expertise.

Extensive practical and solid theoretical knowledge of applicable compliance guidelines of the FDA or other regulatory bodies; and relevant Fareva SOPs.

In addition to high technical competence, understands and can articulate the scientific/regulatory principles that underlie practices and guide future projects/studies/reviews development. Continues to expand breadth of technical expertise.

Ability to interpret and document results according to standard operating procedures using all Quality Systems guidelines.

Demonstrated ability to independently develop, document and troubleshoot methods of moderate complexity.

Ability to lead teams from work cross functional areas

Ability to provide equipment and procedure training and to share technical expertise with less experienced colleagues to solve problems.

Can independently design and carry out a series of studies/reviews to solve a problem or evaluate a process/procedure. Solutions may involve the development of new techniques and procedures. Uses literature and colleagues as resources to solve problems.

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