Validation Specialist at Zoetis, Inc. in Charles City, Iowa

Job Description:

The EMU Validation Specialist is accountable for ensuring cGMP compliance within the site's validation and qualification systems and is expected to provide guidance and support in the enforcement of regulatory guidelines. Primary responsibilities include: Process and Cleaning validation, Equipment and Automation qualification, as well as supporting other compliance activities as needed.

The EMU Validation Specialist may also assist in regulatory agency audits conducted at the site, assist in the review and assessment of Zoetis Quality Standards and provide support for market action activities.

Position Responsibilities:

• Maintain the Cleaning Validation Program


• Ensure all colleagues are adequately trained and continue to receive training on cGMPs, safety, OSHA, technical skills, policies, and procedures. Ensure training documentation is accurate and only trained colleagues are allowed to perform functions. Assures overall quality/integrity of biological products manufactured and distributed in worldwide markets based on 9CFR, applicable cGMP regulations (EU, JP, etc.), and industry standards.


• Support the equipment performance review program.


• Support the validation maintenance program.


• Support the Process Validation Program.


• Engaged in monitoring changes in the external regulatory community.


• Provide technical expertise on product processing steps and equipment performance and capabilities.


• Support and partner closely with team leads, Site colleagues, buyer/planners and other colleagues to ensure master batch records, SOPs, training records and other documents are current and compliant under cGMP conditions - ensure production systems and practices are consistent throughout the organization


• Support the operational excellence initiatives at the site


• Work with Production Leads, VMRD, Quality Operations, EMU, and any team to support execution of process validation & development batches


• Demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance for responsible areas and systems - support team with timely safety investigation closure and ensure safety training and risk assessments are adequate


• Own, investigate, and write associated deviations as well as support & coach Site colleagues in these functions - ensure adoption of 'zero late' mentality in meeting timelines


• Leverage other biologic sites in the network to identify and implement best practices that add value to the business and the site considering the current environment


• Ensure support and coordination of system/process-related validation activities


• Implements strong communication networks for information flow to and from the plant sites, senior management, staff groups and regulatory agencies.


• Ensure continued regulatory compliance within Charles City by actively participating on key teams and task forces and making appropriate recommendations when needed to assure compliance.

EDUCATION AND EXPERIENCE

• Specialist Level: BA/BS with 2-4 years of experience OR MBA/MS with 0-2 years of experience OR Minimum of 8 years relevant experience. BA/BS in Chemistry, Microbiology, Pharmacy or Engineering. Associate Level: BA/BS with 0-2 years of experience OR 6 years relevant experience.


• Thorough knowledge and understanding of biological and pharmaceutical processing (including aseptic, sterilization, depyrogenation processes) and related analytical testing.


• Demonstrated record of successful interaction with senior management, regulatory agencies (e.g. APHIS, USDA, VMD, MCA, FDA) and other internal and external auditing groups.


• Track record of continuous improvement and development/implementation of Best Practices. Familiarity with statistical analysis and strong problem solving skills.


• Must have an understanding of GMP and global regulatory standards.


• Strong communications and planning skills.


• Knowledge of Right First Time principles and tools. Risk Management


• Investigation and Problem Solving


• Organization skills


• Verbal and written communication skills (fluent in English)


• Proficient in Microsoft Office applications


• Attention to detail


• Demonstrated ability to work with internal and external colleagues

Full time

Regular

Colleague

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis. Apply Now