Position Title: Validation Specialist

M-F 1st shift

Summary:

In this critical position, the Validation Specialist is responsible for authoring and executing installation, operation and performance process and equipment qualifications (IOPQ)for the site to ensure compliance with local and global regulatory agency requirements, internal company standards and current industry practices

The Role:

• Generate and execute Validation protocols (IQ/OQ/PQ) of site equipment including production equipment, utilities (as applicable) and other related systems in compliance with applicable regulatory requirements. (EU/GMP, etc.)

• Perform hands on execution of Installation, Operational and Performance Qualifications for equipment, facility, utilities, cleaning, and manufacturing processes in accordance with predefined test protocols.

• Resolve deviations and non-conformances reported during validation/qualification.

• Analyze validation results and compile data into summary reports for initial qualifications and re-qualifications.

• Coordinate testing schedule with impacted area managers and quality control based on project needs.

• Provide input to technical composition of standard operating procedures.•Create department standard operating procedures, review and revise as applicable.

• Investigate and resolve validation problems.

• Participate in equipment failure investigations, corrective/preventive actions and equipment release.

• Contribute to the successful completion of project milestones and crucial technical tasks.•Review and approve validation documentation.

• Assess the impact of changes to validated systems and write protocols to achieve and maintain cGMP compliance.

• Review of change control, SOP’s, calibration, preventative and corrective maintenance documentation for equipment/system to assure that all remain in a validated state (Periodic review of equipment/system).

• Perform other duties as needed

The Candidate

• Bachelor's degree in engineering, Biomedical engineering or equivalent scientific discipline with five plus years related experience in validation in a GMP (Good Manufacturing Practices) environment

• Effective communication.

• Ability to work independently or in a team environment.

• Ability to multi-task and demonstrate diplomatic skills.

• Proficient (excellent) in English verbal and written communication skills to convey and receive ideas and instructions to/from others within and outside the organization

• Ability to effectively present information and respond to questions from peers, management, suppliers and customers

• Strong organizational skills

• Proficient skills in Microsoft Office applications (Word, Excel, PowerPoint, Access)

• Ability to work effectively under pressure to meet deadlines

P osition Benefits:

• 152 hours PTO & 8 Holidays

• Medical, Dental & Vision Benefits and 401k

• Tuition Reimbursement

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 (https://careers.catalent.com/us/en) to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .