Process Scientist

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 Technical & Scientific Affairs Scientist (Process Scientist) is an integral part of our Quality team based out of our Ireland - Sligo site.
Position Details
Education
A minimum of a Masters degree in a technical discipline (e.g.
biochemistry, chemistry, biotechnology, biopharmaceuticals).
A PhD.
is desirable.
Experience
At least 5 years experience in the biotechnology and/or pharmaceutical industry, with Operational experience of new product introductions and product support.
Knowledge of the processes and equipment necessary for the manufacture of pharmaceuticals (oral solid dose), parenterals and/or biologicals
Experience in authoring, review and execution of process validation studies and reports is a must.
Experience with vaccines would be preferable particularly in the area of product development and stewardship.
Experience in cleaning validation is desirable.
Proficient in written and spoken English.
Responsibilities
Plan and coordinate the assigned Technical Transfer (TT) activities to ensure a successful transfer of processes and technology.
This will include:
Developing instructions relating to production operations (tableting/packaging)
Review and report on data relating to TT activities
Working with the scheduling team to schedule TT activities
Support the Manufacturing team throughout the manufacturing process
Developing protocols as required
Focus on assigned Technical Transfer (TT) activities for new products and filling and inspection processes being transferred into the Sligo site.
Use a risk-based approach to TT activities for planning, readiness & execution.
Develop functional partnerships with the required site business units to address TT activity related issues.
Continuously support the manufacturing processes through:
Provide on the floor process support with enhanced support during Engineering runs
Introduce/Establish statistically based tracking metrics
Continuously monitor process CPP's and update the process databases
Raise, investigate and close out non conformances, planned deviations and change control requests
Where required performs sample analysis in accordance with standard operating procedures (SOPs)
Coordinates the use of external test laboratories when required
Present issues relating to TT and routine process monitoring activities to cross functional teams and help develop and deliver business cases for courses of action as appropriate
Develop and maintain the depth of knowledge and commitment to excellence necessary for the manufacture of biological products.
Conduct work activities in compliance with Safety, Health and Welfare at Work legislation and Company policies.
Engage with and Support Quality and Regulatory Audits
Other duties as assigned
Core Competencies
Proactive at keeping current with literature and latest technologies.
An excellent understanding of GMP, ICH and compendia regulations and guidance's.
Demonstrated ability in leading root cause analysis and effective investigation practices.
Excellent problem solving (facilitation and application of tools), risk management and decision making skills
Excellent collaboration skills.
Excellent attention to detail and significant data review experience essential.
Excellent technical writing skills including deviation reports and validation reports.
Effective time management and multi-tasking skills.
Demonstrate ability to drive the completion of tasks, trouble shooting skills and excellent attention to detail.
Excellent communication skills, both verbal & written.
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: Quality
Location: Ireland - Sligo
Work Schedule: Monday - Friday (39 Hours)
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