Senior Validation Specialist
Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with approximately 6,500 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive medicine (infertility), urology, gastroenterology, endocrinology, maternal health (obstetrics/gynecology), orthopedics and Oncology. Ferring's US operations employ approximately 900 people.
People Come First At Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.
Please see below responsibilities and requirements.
Will be responsible for the following:
Will be responsible to:
assist / mentor Validation Specialists on GMP Impact Assessments, System Component Criticality Reviews, Traceability Matrixes, Design Qualification, Vendor documentation checklists that they are working on.
Will also monitor and track these documents to ensure that they are completed on time.
Mentor / train / assist Validation Specialists with Cleaning Validation, Equipment / Utilities Qualification, Process Validation, Computer Validation principles.
Review, supervise, and track commissioning, qualification, validation projects from other Validation Specialists and / or Validation contractors through Microsoft Project or tracking spreadsheets to ensure work is completed on time.
SME on at least two (2) of the Qualification / Validation subjects specified below and thorough hands on experience on at least seven (7) of the ten (10) subjects:
Sterile Process Equipment Qualification
Packaging Equipment Qualification
Utilities Commissioning / Qualification
Cleaning Verification / Validation
QC Equipment Qualification
QC Test Method Validation
Environmental Monitoring Qualification of Classified Areas
Complete Trackwise deviations and qualification / validation deviations related to equipment / instrument, cleaning and process non-conformances. Also lead Trackwise deviations, CAPA's and change controls issued to the department. Ensure that they are properly tracked, closed on time or extended if necessary.
Be able to answer questions during internal and external audits.
Take the lead in ensuring that deviations, CAPA's, and change controls issued to the department are properly tracked, closed on time, or extended if necessary.
Update yearly Validation Master Plan.
Bachelor's degree in Engineering or related field, or equivalent combination of education and work-related experience, required.
Minimum 5+ years Qualification (IQ, OQ, PQ) / Validation (PV, CV) experience.
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.
If you need assistance during the application process due to a disability, please email email@example.com.
Ferring Pharmaceuticals, Inc.