About Phibro Animal Health Corporation Phibro Animal Health Corporation is a publicly traded, global organization with a rich history in animal health and nutrition as a manufacturer and marketer of medicated feed additives, vaccines, nutritional specialty products, and mineral nutrition. We strive to be a trusted partner with livestock producers, farmers, veterinarians, and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals. Phibro is a diversified company in manufacturing and marketing products for ethanol performance, microbials for plants, home and industrial applications, and specialty chemicals for various industrial markets. In addition to, Phibro’s revenues are in excess of $1 billion and are supported by over 2,300 employees worldwide. At Phibro, people are our greatest asset. We strive to develop a diverse workforce that fosters an environment where people feel supported in openly sharing their creativity and skills that allows them to be the most successful that they can be. Position Details The Regulatory Affairs Associate is an integral part of our Regulatory Affairs team based out of our Ireland - Sligo site. Key Requirements Understanding of the international and European Veterinary Medicines regulatory framework and guidelines. Understanding of the Regulatory Submission procedures in EU and the international area. Understanding of the Labelling and artwork management. Requirements Technical knowledge about Veterinary Medicines quality/safety/efficacy requirements. Responsibilities Provide regulatory support for the company’s veterinary vaccine portfolio. Support all regulatory aspects of assigned projects in accordance with the business strategy, priorities and timelines. Establish and maintain effective working relationships with other PAHC business units (Manufacturing, Quality and Marketing) to ensure regulatory perspectives are incorporated into business plans. Supports all types of product lifecycle activities. Supports writing responses to questions raised by regulatory authorities. Prepare and organize the regulatory package submission to the different countries (international area). Cross Functions Support Supports quality in implementing Regulatory authorities approvals. Supports Supply chain with regulatory information on the products. Supports CCP process by assessing impact of the changes on existing registrations and implement the variation process. Ensures the Artwork management process is under control, approved artworks are communicated to the right stakeholders on time. Education & Experience Minimum of a bachelor’s degree in a relevant scientific or veterinary discipline. At least 3-5 years’ experience in international pharmaceutical industry, including experience in regulatory. Ideally experience with veterinary vaccines and/or products derived using rDNA technology. Proficient in scientific written and spoken English. Additional language skills are a plus. Personal Attributes Self-starter takes initiative. Team player essential. Ability to handle several projects simultaneously. Good organizational, prioritization and time management skills. Can work effectively under pressure. Excellent attention to detail. Proactive: identify regulatory risks and propose solutions. Demonstrate integrity. Benefits To learn more about Phibro Animal Health's competitive benefits package, please click here: Phibro Benefits . Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, gender identity, veteran status, marital status or any other characteristics protected by law. Business Unit Animal Health & Mineral Nutrition Division Animal Health & Nutrition Department Regulatory Affairs Location Ireland - Sligo Work Schedule Monday - Friday (40 Hours) #J-18808-Ljbffr
A global animal health organization is seeking a Regulatory Affairs Associate at its Sligo site. This position requires a solid understanding of international veterinary medicines regulations and includes providing support for the company's veterinary vaccine portfolio. The successful candidate will have a bachelor’s degree in a relevant scientific or veterinary field, and ideally 3-5 years of experience in the pharmaceutical industry. Strong English communication skills and the ability to work under pressure are essential. This role offers a collaborative environment across various departments. #J-18808-Ljbffr
About Phibro Animal Health Corporation Phibro Animal Health Corporation is a publicly traded, global organization with a rich history in animal health and nutrition as a manufacturer and marketer of medicated feed additives, vaccines, nutritional specialty products, and mineral nutrition. We strive to be a trusted partner with livestock producers, farmers, veterinarians, and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals. Phibro is a diversified company in manufacturing and marketing products for ethanol performance, microbials for plants, home and industrial applications, and specialty chemicals for various industrial markets. In addition to, Phibro’s revenues are in excess of $1 billion and are supported by over 2,300 employees worldwide. At Phibro, people are our greatest asset. We strive to develop a diverse workforce that fosters an environment where people feel supported in openly sharing their creativity and skills that allows them to be the most successful that they can be. If you are interested in working for Phibro and feel that you do not meet all qualifications, we encourage you to apply as you might be the right candidate for this role or other positions. The Graduate Engineer is an integral part of our Engineering team based out of our Ireland - Sligo site. Position Details We are seeking a motivated and detail-oriented Graduate Engineer to join our team at a EU GMP compliant vaccine manufacturing facility. This is an exciting opportunity to be involved in validation, qualification, and routine support of critical equipment and cleanroom environments. Key Responsibilities: Temperature Mapping and Environmental Monitoring: Plan, execute, and document temperature mapping studies for storage areas (cold rooms, freezers, incubators, warehouses) and critical process equipment. Perform risk assessments to define mapping strategy and sensor placement. Analyze data for compliance with EU GMP and internal quality standards. Generate and review validation protocols and reports (IQ/OQ/PQ). Autoclave Load Qualification: Support the qualification of autoclaves, including moist heat sterilization cycles. Develop and execute load patterns and thermal distribution/equilibration studies. Ensure Biological Indicators (BIs) and thermocouples are placed per GMP requirements. Analyze cycle performance data and support requalification activities. Equipment Qualification and Validation: Assist with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing equipment (e.g., HVAC, clean steam, washers, filling lines, isolators). Support validation life cycle documentation and change control processes.Collaborate with cross-functional teams (QA, Manufacturing, Maintenance). Cleanroom and Facility Support: Support routine cleanroom qualification (HEPA integrity testing, airflow visualization, pressure differential monitoring). Participate in periodic requalification and deviation investigations. Assist in maintaining the state of control of classified environments. Other duties as assigned. Documentation and Compliance: Prepare and review engineering documentation in compliance with EU GMP Annex 15, EMA, and FDA standards. Completion of work orders in the engineering system Follow Good Documentation Practice (GDP) and support audit readiness. Contribute to continuous improvement initiatives and deviation/CAPA investigations. Essential Education and Experience: Bachelor’s degree in Mechanical, Chemical, Biomedical, or Process Engineering (or equivalent). Strong interest in GMP-regulated pharmaceutical/biotech manufacturing. Familiarity with validation principles and GMP guidelines (e.g., Annex 15, ICH Q8/Q9/Q10). Proficient with Microsoft Office. Excellent attention to detail, analytical mindset, and willingness to learn. Strong written and verbal communication skills. Desirable Education and Experience: Internship or co-op in a regulated manufacturing or laboratory setting. Experience with GxP documentation or working in a cleanroom environment. Basic understanding of equipment like autoclaves, clean steam systems, HVAC systems, and temperature control devices. To learn more about Phibro Animal Health's competitive benefits package, please click here: Phibro Benefits . Phibro is an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, gender identity, veteran status, marital status or any other characteristics protected by law. Business Unit: Animal Health & Mineral Nutrition Division: Animal Health & Nutrition Department: Engineering Location: Ireland - Sligo Work Schedule: Monday - Friday (39 Hours) #J-18808-Ljbffr
A leading animal health company is seeking a motivated Graduate Engineer for its Sligo facility. This role involves validation and qualification of critical equipment in a GMP-compliant vaccine manufacturing environment. The ideal candidate will possess a degree in a relevant engineering discipline, along with strong attention to detail and a keen interest in pharmaceutical manufacturing. Join our engineering team and contribute to maintaining high-quality standards in animal health products. #J-18808-Ljbffr
