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Cleaning Validation Engineer

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  • ID: 538529
  • Posted: 4/18/2024
  • Location: Decatur, IL
  • Category: Pro - Engineering
  • Job Type: Direct Placement
  • Duration: Direct Placement

Description

Are you a Cleaning Validation Engineer who is looking to join one of the top companies within the pharmaceutical industry?

Are you looking to further your career and grow?

Do you have experience with Equipment and Instrument Standards used for validation executions?

If you answered yes to those three questions, then apply today!

Acara Solutions seeks highly qualified candidates to work Onsite with our client in Decatur, IL. Interested?

Here's what you'd do:

  • The successful candidate is an SME in cleaning and sanitization effectiveness validation and has knowledge of equipment and process validation. 
  • The Engineer prepares product contact surface cleaning and room and equipment sanitization effectiveness validation, process and equipment validation protocols, protocol final reports and procedural documentation.
  • Responsibilities include coordinating validation activities with departments and personnel and maintaining the cleaning validation processes and procedures.
  • As the cleaning validation SME, the candidate is knowledgeable in cleaning validation concepts, practices, procedures and leads and instructs others supporting cleaning validation deliverables.
  • Cleaning Validation Responsibilities 
  • Writing and reviewing cleaning and sanitization procedures and maintaining the Cleaning Validation Master Plan.
  • Execution of cleaning validation protocol activities and sample collection.
  • Responsible for adherence to FDA guidance and regulatory requirements and Client Validation Master Plans.
  • Preparing, reviewing, and executing related validation studies such as extraction and recovery studies for product contact surfaces and equipment surfaces.
  • Preparing and executing cleaning development protocols including lab scale, full scale spray coverage testing, and full-scale cleaning recipe and procedure development.
  • Preparing risk assessment and reports summarizing data and determination of cleaning matrix and critical cleaning parameters for validation. Assess new products being introduced to the site for alignment within the approved cleaning matrix.
  • Assessment, preparation, and execution of sanitization effectiveness study protocols with Microbiology Lab for active and new sanitizing agents on room and work surfaces.
  • Assisting in investigations, i.e., deviations during the execution of protocols and continuous monitoring activities and providing documentation to support the findings of the investigation.
  • Lead development projects when modifications are required and implementation of new cleaning equipment/processes.
  • Preparing SOPs and providing training to staff on the cleaning validation approach procedures.
  • New cleaning equipment URS, FAT, SAT, IQ, OQ and PQ document generation and execution.
  • Perform periodic cleaning validation verification studies.
  • SME for presentation of cleaning validation to Regulatory (FDA), internal and external auditors.
  • Equipment and Process Validation Responsibilities Scheduling, planning and execution of equipment and process qualifications meeting approved schedules.
  • Coordinating validation activities with other departments. 

 

Here's what you'll get:

Hours: 40 Hours per week

Length: Direct Placement

 

Sound like a good fit?

APPLY TODAY

About Acara Solutions

Acara is a premier provider of recruiting and workforce solutions-we help companies compete for talent. With a legacy of experience in a variety of industries around the world, we partner with clients, listen to their needs, and customize visionary talent solutions that drive desired business outcomes. We leverage decades of experience to deliver contingent staffing, direct placement, executive search, and workforce services worldwide.

 
Job Requirements

 
Required Skills / Qualifications:
  • Bachelor's Degree in Microbiology or Biology or Engineering or Chemistry
  • Minimum of 5 years' experience with Equipment and Instrument Standards used for validation executions
  • Minimum of 5 years' experience with cleaning validation in a pharmaceutical operation
Preferred Skills / Qualifications:
  • Keeps abreast of current developments and trends in areas of expertise.
  • Ability to independently write clear and concise technical reports, process descriptions, and standard operating procedures..
  • Ability to hear accurately the spoken word with moderate office noise or plant noise.
  • Ability to apply deductive reasoning and understand complicated issues.
  • Ability to receive instructions and follow work rules and company policies.
  • Ability to follow safety and security practices.
  • Ability to meet deadlines and effectively deal with office stress.
  • Ability to accurately communicate ideas, facts, and technical information.
  • Maintain confidentiality of certain information.

Additional Information:

  • Upon offer of employment, the individual will be subject to a background check and a drug screen.
  • In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
  • While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear.
  • The employee use hands to finger, handle, or feel.
  • Specific vision abilities need by this job include close vision for written work and PC use 

Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.

Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.
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