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Senior Validation Specialist

4 months ago

Parsippany, United States Ferring Pharmaceuticals Inc. Full time
Job Description:

As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and 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 plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease.

As the Senior Validation Specialist, you will test and document the validity and accuracy of manufacturing systems and equipment. Tests processes and manages process validations. Provides technical support and implement operating procedures. Create documentation to show that a manufacturing or production process has consistent results and meets quality standards.

With Ferring, you will be joining a recognized leader, identified as one of "The World's Most Innovative Companies" by Fast Company, and honored by Fortune with inclusion on its "Change the World List," for addressing society's unmet needs. Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country.

Responsibilities:
  • Lead and manage multiple commissioning / qualification / validation activities performed at facility with minimal supervision.
    • Equipment Qualification / Re-Qualification (IQ, OQ, PQ) for process equipment, QC equipment, packaging equipment, clean utilities.
    • Cleaning Verification / Validation studies for transferred products.
    • Media Fills / process simulations protocols.
    • Engineering protocols to support packaging validation / shipping study activities.
    • Trackwise deviations and qualification / validation deviations related to equipment / instrument, cleaning, and process non-conformances.
    • Assist in execution of Process Validation and Engineering studies.
  • Review commissioning, qualification, validation projects performed by Validation Specialists and / or Validation contractors.
  • Generate Validation Master Plans (VMPs) and Risk Assessments related to large level qualification projects.
  • Monitor and track protocol and report status.
  • Complete GMP Impact Assessments, System Component Criticality Reviews, Traceability Matrixes, Design Qualification, Vendor documentation checklists, and final handover of documents to Operations with minimal supervision.
  • Mentor and train junior level Validation Specialists on various validation tasks.
  • Plan and complete commissioning, qualification, and validation activities performed in facility.
  • Complete Trackwise deviations and qualification / validation deviations related to equipment / instrument, cleaning, and process non-conformances, and assist Validation Specialist with same activities.
  • Resolve observation / CAPAs generated from internal and external cGMP audits related to Validation, Qualification, and Commissioning studies.
  • Participate and able to answer questions during intern and external audits, as needed.
  • Close change controls, CAPAs, and investigations, as well as ensure deviations, CAPAs, and change controls issued to the department(s) are tracked (closed on time, or extended if necessary.)
  • Prepares Final Reports summarizing the results of executed Validation / Qualification studies and address comments and questions from reviewers / approvers.
  • Assist Production, Engineering, and/ or IT in improving / optimizing performance of process / packaging equipment.
  • Update yearly Validation Master Plan.
Requirements:
  • Bachelor's degree in engineering or related field, or equivalent combination of education and work-related experience, required.
  • Minimum 5 years of hands-on experience in validation (PV, CV), specifically within the pharmaceutical sector.
    • Subject matter expert in at least two (2) of the Qualification / Validation subjects specified below
      • Sterile Process Equipment Qualification
      • Packaging Equipment Qualification
      • Media Fills
      • Utilities Commissioning / Qualification
      • Cleaning Verification / Validation
      • Process Validation
      • QC Equipment Qualification
      • Computer System Validation
      • Environmental Monitoring Qualification of Classified Areas
  • Understanding of validation principles, current Good Manufacturing Practices (cGMP), and applicable regulatory requirements
  • Proficiency in equipment and process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Excellent problem-solving and analytical skills.
  • Strong communication and teamwork abilities.
  • Ability to work independently in a timely manner.
  • Weekday late nights and weekends, may be required.
Physical Requirements:
  • Sitting and Computer Work: A significant portion of the work may involve sitting at a desk, using a computer, and reviewing and documenting validation data, reports, and protocols.
  • Standing and Walking: Some tasks, such as equipment inspections or on-site validations, may require standing and walking within a manufacturing or laboratory environment.
  • Lifting and Carrying: Occasional lifting and carrying of equipment or validation materials may be necessary.
  • Fine Motor Skills: The ability to operate various testing and measurement equipment and to complete detailed documentation with precision is important.
  • Safety Equipment: The use of personal protective equipment (PPE), such as lab coats, safety glasses, gloves, and ear protection, may be required to ensure safety and compliance with regulations.


Ferring + you

At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry's most impressive people, these are just some of the ways we live our "People First" philosophy.

Our Compensation and Benefits

At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $61,750 to $143,000 , which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. [Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.

Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 401k plan and company match, short and long-term disability coverage, basic life insurance, wellness benefits, reimbursement for certain tuition expenses, sick time of 1 hour per 30 hours worked, vacation time for full time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment as well as 12 to 13 paid holidays per year. We are proud to offer 26 weeks of paid parental leave, learn more about the parental leave offering in our benefits package here.

Ferring is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local laws.

Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.

We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace.

Location:
Parsippany, New Jersey