Contribute to outstanding innovation
Make braver choices
As a privately-owned, specialty healthcare company, Ferring focuses on developing life-changing innovations that help people live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale while remaining agile and true to our people first philosophy. Built on a 70-year commitment to science and research, Ferring is relentless in pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the worlds oldest enemy: disease.
Responsible for preparing and executing commissioning, qualification, and validation studies for new facilities, processes, and equipment as well as assisting in maintaining the facility, processes, and equipment in a validated state.
- Supports validation activities in a cGMP regulated manufacturing environment. The position will prepare, review, and execute commissioning, qualification (IQ, OQ, PQ), and validation (PV and CV) documents for facilities, processes, and equipment.
- Supports Project Teams in: GMP Impact Assessments, Instrument Criticality Lists, Critical Components Lists, Requirements Traceability matrices, Design Qualification, Vendor documentation checklists, final handover of documents to Operations.
- Aids in the planning of commissioning, qualification and validation activities and in interfacing with Validation Contractors, QA, Production Operators, and Engineering.
- Ability to handle multiple commissioning, qualification, validation priorities based on the needs of the manufacturing area with guidance from management.
Participates on and supports validation projects within the manufacturing areas including but not limited to:
- Validation and implementation of new or transferred manufacturing process and cleaning validations;
- Design and execute engineering (pre-validation) studies to support validation activities.
- Assisting in troubleshooting of process issues, process characterization and root cause investigations.
- Involved in resolving deviations / non-conformances observed during execution of qualification and validation activities.
- Interacts / assists in internal and external cGMP audits.
- Ability to prepare / issue change controls, CAPAs, and investigations.
- Prepare Final Reports summarizing the results of executed Validation / Qualification studies.
- Bachelors degree in Engineering or related field, or equivalent combination of education and work-related experience, required.
- Minimum 1-5 years Qualification (IQ, OQ, PQ) / Validation (PV, CV) experience.
- Demonstrates potential for technical proficiency, engineering creativity, collaboration with others, and independent thought.
- Demonstrated troubleshooting and problem solving skills including the use of designed experiments.
- Ability to handle multiple tasks/projects
- Good influencing and negotiation skills to accomplish the same goals for internal and external stakeholders according to Project and business need.
- Understanding engineering disciplines, work package management and work package control.
- Knowledge of Microsoft office applications.
Join our team and youll become part of a close-knit family one in which youll be listened
to and your contributions valued. Surrounded by like-minded people, youll have the support to achieve more. So if you love to come up with new ways to make a positive difference and see them through, welcome to the team.
We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected
Veterans/Disabled. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Location/Region: Independence, MO