Campus Pride Jobs

sr validation engineer.

• morton grove , illinois

• posted may 22, 2024

job details

summary

• $80,000 - $100,000 per year

• permanent

• bachelor degree

• category life, physical, and social science occupations architecture and engineering occupations

• reference48177

job details

job summary:

Randstad is the #HR Solutions company in the world and we are sourcing for a Sr Validation Engineer in the Suburbs of Chicago, IL. This position is responsible for managing the Sanitization Program for the site. Position requires knowledge of Cleaning, Sanitization and Validation for OTC, pharmaceuticals and cosmetics. The position will be the Subject Matter Expert and be able to support the facility 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. This is a direct hire role and can start immediately.

location: Morton Grove, Illinois

job type: Permanent

salary: $80,000 - 100,000 per year

work hours: 8 to 4

education: Bachelors

responsibilities:

Job 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.

qualifications:

Education and Experience

• BS degree in Biology, Chemistry, Microbiology, Biochemistry or relevant science discipline - 3 to 5 years of relevant Quality experience preferably in the pharmaceutical industry.

• Must have a strong background in Cleaning and sanitization program and validations

• Mentor/trains in routine procedures demonstrating expertise.

Technical Skills Requirements

• 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 in order to solve problems.

skills: Quality control, SOP, Quality Assurance, CAPA, Biology, Chemistry, GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice), Sanitation, Manufacturing Operations, Process Engineering

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

Applications accepted on ongoing basis until filled.