Validation Engineer

USA LE; Minneapolis (MN); Presencial; USD 77.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Healthcare (medical, dental, andvision

401(k) with company match

Disability insurance

Life Insurance

Wellness benefits

Tuition reimbursement

Paid time off

Paid holidays

Annual incentive/bonus targets

Descripción de la vacante

Ferring is seeking a Validation Engineer to prepare and execute commissioning, qualification, and validation for processes, materials, equipment, cleaning, and computerized systems/software. The role supports validation activities in a cGMP manufacturing environment and collaborates with project teams on GMP impact assessments, traceability matrices, and risk assessments.

You will manage multiple validation priorities, participate in pre-validation studies, assist in deviation investigations,

Formación

• 3–5 years qualification/validation experience in a regulated environment.
• Experience with Material Qualification, Computerized System/Software Validation and Process Validation.
• GMP experience and structured problem-solving approach.

Responsabilidades

• Support validation activities in a cGMP manufacturing environment and prepare/execute QC documents.
• Assist in GMP Impact Assessments, User Requirements, Traceability Matrices and Risk Assessments.
• Coordinate multiple validation priorities with management guidance.
• Validate new or transferred processes and cleaning validations; perform pre-validation studies.
• Troubleshoot process issues and participate in deviations, CAPAs, and investigations.
• Assist in change controls and investigations; take on other duties as assigned.

Conocimientos

Validation experience

Risk assessments

Engineering problem solving

Educación

Bachelor's degree in engineering or relevant field

Herramientas

Microsoft Office (Word, Excel)

Descripción del empleo

Job Description:

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.

Summary: The Validation Engineer will be responsible for preparing and executing commissioning, qualification, and validations for new processes, materials, equipment, cleaning, and computerized systems/software.

Responsibilities

• Support validation activities in a cGMP regulated manufacturing environment. The position will prepare, review, and execute commissioning, qualification and validation documents for processes, materials, equipment, cleaning, and computerized systems/software.


• Support Project Teams in: GMP Impact Assessments, User Requirement Specifications, Traceability Matrices, Design Qualifications and Risk Assessments.


• Ability to handle multiple commissioning, qualification, and validation priorities based on the needs of the manufacturing area and project team with guidance from management.


• Participating in and support 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.
  
  
  • Assist in troubleshooting process issues, process characterization and root cause investigations.
  
  
  • Involved in resolving deviations/non-conformances observed during execution of qualification and validation activities.
  
  
  • Ability to prepare/issue change controls, CAPAs, and investigations.
  
  
  
  


• Other duties and tasks assigned

Requirements

• Bachelor's degree in engineering or relevant field or equivalent experience

Experience

• Minimum 3-5 years qualification/validation experience. Experience in the following areas preferred:
  
  
  
  • Material Qualification
  
  
  • Computerized System/Software Validation
  
  
  • Process Validation
  
  
  • Regulated industry experience required (GMP Preferred)
  
  
  • Ability to apply sound engineering logic to solve complex problems, assess risks, and make decision accordingly
  
  
  • Proficiency with Microsoft Office programs such as Word and Excel
  
  
  
  

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 $76,500 to $110,000, 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.

• 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 150 hours in the first four (4) years of employment


• 187.5 hours in the fifth (5th) year of employment


• 15 paid holidays per year


• annual incentive compensation targets in the form of an annual bonus

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.

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