Staff Product Validation Engineer

Thermo Fisher Scientific; Santa Clara (CA); On-site; USD 112,000 - 168,000; Full time

Job summary

Join a leading company in the pharmaceutical manufacturing sector as a Staff Product Validation Engineer. This role involves ensuring product quality and compliance through validation and testing processes, requiring a background in Bioprocessing and experience in managing complex systems. The successful candidate will develop comprehensive validation plans and collaborate with several teams to integrate validation activities seamlessly.

Benefits

Comprehensive medical and dental plans

401(k) retirement savings plan

At least 120 hours paid time off

Tuition reimbursement

Employee Stock Purchase Plan

Qualifications

• 5+ years of validation experience in the Bioprocessing industry.
• 7+ years of product or process validation experience.
• Certification in Lean, Six Sigma, or Project Management is a plus.

Responsibilities

• Develop and implement validation plans and protocols.
• Lead validation activities including IQ, OQ, and PQ.
• Analyze validation data and prepare reports.

Skills

Validation principles

Data analysis

Problem-solving

Communication

Attention to detail

Education

Bachelor of Science degree in Engineering or Science

Tools

Agile PLM

JIRA

Trackwise Systems

Job description

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Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Join us as we expand our business and quality department, which is passionate about revolutionizing the way things are done in our industry! We are seeking a highly skilled and experienced Senior Product Validation Engineer to join our team. The successful candidate will play a meaningful role in ensuring our products' quality, reliability, and compliance through meticulous validation and testing processes. This is an excellent opportunity for a professional with a strong background in product validation, particularly within the bioprocessing or biopharma industry. Join us in creating exceptional and functional experiences.

What will you do?

• Develop and implement comprehensive validation plans, protocols, and reports for Bioprocess systems.
• Lead product validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Coordinate and carry out validation testing according to regulatory requirements and industry standards.
• Perform risk assessments and develop mitigation strategies to address potential product validation issues.
• Analyze validation data to identify trends, discrepancies, and areas for improvement.
• Prepare detailed validation reports and present findings to multi-functional teams and management.
• Collaborate with R&D, manufacturing, quality, and other departments to ensure seamless integration of validation activities.
• Manage and maintain accurate and organized validation documentation and records.
• Ensure all validation activities are detailed in compliance with regulatory and company requirements.
  
  

How will you get here?

Education:

• Bachelor of Science degree in Engineering or Science field and 5+ years of validation experience in the Bioprocessing industry or equivalent validation cGMP experience.
  
  

Experience:

• Minimum of 7+ years of product or process validation, Manufacturing, or Quality Engineering, or equivalent role.
• Strong understanding of validation principles, methodologies, and regulatory requirements.
• Strong background in completing validation protocols for complex systems.
• Extensive experience in solving coordinated systems and resolving technical issues independently.
• Advanced knowledge of Bioprocessing equipment architecture, network infrastructure, and process control solutions such as DeltaV DSC or PLCs is a plus.
• Proficiency in data analysis and statistical tools.
• Familiarity with bioprocessing equipment and systems.
• Detailed, with a focus on maintaining high standards of quality and compliance.
• Certification in relevant areas (e.g., Lean, Six Sigma, Project Management) is a plus.
  
  

Knowledge, Skills, Abilities:

Proven ability to effectively communicate with customers and internal partners to achieve a great outcome for everyone.

Understand electrical and mechanical assembly drawings is a must.

Attention to detail for documentation completion.

Familiarity with Agile PLM, ERP Systems, JIRA, and Trackwise Systems.

Familiarity with Emerson DeltaV Automation and Control Platform or similar advanced process control systems is a plus.

Must be able to multitask and respond to shifting priorities.

Must be dedicated to achieving desired outcomes.

Must have prior mechanical and process equipment experience.

Technical or Engineering background with strong analytical and interpersonal skills.

Able to travel occasionally (<15%), domestic or international

Physical Abilities:

• Ability to lift and carry items weighing 40 lbs.
• Ability to work in office and manufacturing environments.
• Ability to get down on the floor and/or climb ladders.
• Ability to effectively use computer-based software, such as Microsoft Office suites, and hardware on laptops, tablets, and mobile devices.
  
  

Compensation And Benefits

The salary range estimated for this position based in California is $112,500.00–$168,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
  
  

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance, Product Management, and Engineering

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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