Staff Product Validation Engineer

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

Job summary

An established industry player is seeking a Senior Product Validation Engineer to enhance their quality department. This role is pivotal in ensuring product quality, reliability, and compliance through thorough validation and testing processes. The ideal candidate will have a strong background in bioprocessing or biopharma, with experience in developing validation plans and leading validation activities. Join a dynamic team focused on innovation and quality in a collaborative environment, where your expertise will directly impact product excellence and regulatory compliance.

Benefits

Health plans

Paid time off

Parental leave

401(k)

Stock purchase plan

Qualifications

• 3+ years of validation experience in the bioprocessing industry.
• Strong understanding of validation principles and regulatory requirements.

Responsibilities

• Developing and implementing validation plans and protocols.
• Coordinating validation testing in compliance with regulatory standards.

Skills

Effective communication

Attention to detail

Data analysis

Ability to multitask

Education

Bachelor's degree in Engineering or Science

Tools

Agile PLM

ERP

JIRA

Trackwise

Emerson DeltaV

Job description

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 crucial 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.

Responsibilities include:

1. Developing and implementing validation plans, protocols, and reports for bioprocess systems.
2. Leading validation activities such as IQ, OQ, and PQ.
3. Coordinating validation testing in compliance with regulatory standards.
4. Performing risk assessments and developing mitigation strategies.
5. Analyzing validation data for trends and improvements.
6. Preparing validation reports and presenting findings.
7. Collaborating with R&D, manufacturing, quality, and other departments.
8. Maintaining validation documentation and records.
9. Ensuring compliance with regulatory and company requirements.

Minimum qualifications:

• Bachelor's degree in Engineering or Science with 3+ years of validation experience in the bioprocessing industry or equivalent validation cGMP experience.
• At least 3 years of validation, manufacturing, or quality engineering experience.
• Strong understanding of validation principles and regulatory requirements.
• Experience with validation protocols for complex systems.
• Knowledge of bioprocessing equipment architecture, network infrastructure, and process control solutions is a plus.
• Proficiency in data analysis and statistical tools.
• Familiarity with bioprocessing equipment and systems.
• Details-oriented with a focus on quality and compliance.
• Relevant certifications (e.g., Lean, Six Sigma, Project Management) are a plus.

Skills and abilities:

• Effective communication with customers and internal teams.
• Ability to understand electrical and mechanical drawings.
• Attention to detail in documentation.
• Familiarity with Agile PLM, ERP, JIRA, and Trackwise systems.
• Experience with Emerson DeltaV or similar process control platforms is a plus.
• Ability to multitask and adapt to shifting priorities.
• Mechanical and process equipment experience.
• Strong analytical and interpersonal skills.
• Ability to travel occasionally (<15%), domestically or internationally.

Physical requirements:

• Ability to lift and carry 40 lbs.
• Work in office and manufacturing environments.
• Ability to work on the floor and climb ladders.
• Proficiency with computer software and hardware.

Compensation and benefits:

The estimated salary range in California is $112,500–$168,000. Benefits include health plans, paid time off, parental leave, insurance, 401(k), stock purchase plan, and more. For details, visit: Total Rewards.