Validation Specialist

by Catalent Pharma Solutions

Location: Strathroy, ON
Date Posted: Jul 29, 2022
Catalent Pharma Solutions

Job Description

 
Validation Specialist

 

Position Summary

 

The Validation Specialist reports to the Director, Technical Services.  

 

Reporting to the Director, Technical Services, the Validation Specialist will lead projects which include activities such as facility qualification, equipment qualification, computer validation, and cleaning validation.  The Validation Specialist will have a working knowledge of various aspects of implementing the drug development process in a regulated environment and engineering design, including topics such as Quality by Design (QbD), Design of Experiment (DOE), Good Engineering Practices, data integrity and compliance with all regulatory guidelines.

 

The Role

 

  • In collaboration with R & D, QA and Operations plan, coordinate and drive assigned projects which include activities related to the qualification and validation of introduction, optimization, scale up or changes to facilities, equipment, computer systems, and cleaning procedures, by working with staff and Project Management, within the Catalent Project Management framework, to ensure timelines are met; road blocks are identified early; and resources are coordinated.
  • Work with R & D, QA and Operations and participate in the evaluation and risk assessment of project data in order to:  implement products and technologies into commercial production; ensure all introductions and changes are appropriately documented demonstrating proper design, qualification, operation and maintenance; assess changes to ensure validation status is maintained; and ensure introduction and changes to facilities, equipment, computer systems, and cleaning procedures meet their intended purposes
  • Represent department on technical basis for assigned projects.
  • Effectively communicate on a timely basis with management and other departments within Catalent and customers to ensure clear understanding and acknowledgement of project status, risks, actions and outcomes.
  • Keep updated on regulatory guidelines
  • Prepare and execute validation plans, validation/qualification protocols, validation/qualification reports and study protocols, as appropriate.
  • Participate in risk assessments to develop validation/qualification approaches
  • Operate under and maintain GMP conditions
  • Represent projects at local, technical and customer meetings.
  • Must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met.
  • Perform other duties as required.

 

 

The Candidate

 

Education:

  • Bachelor’s Degree in Engineering (Chem., Indus., Mech., Elec.), life science (Chemistry, Biochemistry, Biology) or related field.

 

Experience:

  • Minimum 0-2 years of experience in validation within a pharmaceutical manufacturing environment.
  • Experience working in a manufacturing, pharmaceutical and/or GMP facility an asset.

 

Skills Required:

  • Knowledge of pharmaceutical manufacturing processes.
  • Organized, good writing skills, meticulous
  • Good computer skills (Word Excel)

 

While performing the responsibilities of the job, these work environment characteristics are representative of the environment the employee will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.

The noise level in the work environment is usually quiet to moderate.

Regular working hours: 8:00 AM – 4:30 PM or 8:30 AM – 5:00 PM with a 30-minute unpaid lunch.

 

These physical demands are representative of the physical requirements necessary for an employee to successfully perform the essential duties of the job. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions of the job.

 

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to sit and use their hands and fingers, to handle or feel and to manipulate keys on a keyboard. Use of manual dexterity is required. The employee is occasionally required to stand, walk, reach with arms and hands, bend or twist, and to stoop, kneel, crouch or crawl. Vision abilities required by this job include close vision.

There is also the potential exposure to chemicals.

 

Catalent. More products. Better treatments. Reliably supplied. ™
Visit www.catalent.com/careers to apply online and explore career opportunities.

Catalent is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin or disability. Accommodations are available for applicants with disabilities throughout the recruitment process upon request. If you are selected for an interview and require accommodation for interviews or other meetings, please advise Human Resources as soon as possible.

Catalent offers rewarding opportunities to further your career!  Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. 

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

   

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

 

Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.

 

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

    

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

 


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