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Biotech Validation Jobs in Texas (NOW HIRING)

PSC Biotech

Business Development Manager

Dallas, TX · On-site

Your Role The Business Development Manager is a quota-bearing individual contributor responsible for selling PSC Biotech's professional services across validation, quality, engineering, and related ...

Danaher

Senior Engineer, Process Validation

Houston, TX · On-site +1

$100K - $130K/yr

... biotechnology? At Aldevron, one of Danaher's 15+ operating companies, our work saves lives-and we ... The Senior Engineer, Process Validation is responsible for leading & supporting internal and ...

Danaher

Senior Engineer, Process Validation

Dallas, TX · On-site +1

$100K - $130K/yr

... biotechnology? At Aldevron, one of Danaher's 15+ operating companies, our work saves lives-and we ... The Senior Engineer, Process Validation is responsible for leading & supporting internal and ...

Danaher

Senior Engineer, Process Validation

Houston, TX · On-site +1

$100K - $130K/yr

... biotechnology? At Aldevron, one of Danaher's 15+ operating companies, our work saves lives-and we ... The Senior Engineer, Process Validation is responsible for leading & supporting internal and ...

Danaher

Senior Engineer, Process Validation

Dallas, TX · On-site +1

$100K - $130K/yr

... biotechnology? At Aldevron, one of Danaher's 15+ operating companies, our work saves lives-and we ... The Senior Engineer, Process Validation is responsible for leading & supporting internal and ...

Deloitte

System Test and Validation Lead

Westlake, TX · On-site +1

... pharma, biotech, medical device, or clinical * Experience leading validation deliverables for GxP systems, including IQ/OQ/PQ protocols, validation plans, summary reports, user requirements ...

Deloitte

System Test and Validation Lead

Austin, TX · On-site +1

... pharma, biotech, medical device, or clinical * Experience leading validation deliverables for GxP systems, including IQ/OQ/PQ protocols, validation plans, summary reports, user requirements ...

Deloitte

System Test and Validation Lead

Austin, TX · On-site +1

... pharma, biotech, medical device, or clinical * Experience leading validation deliverables for GxP systems, including IQ/OQ/PQ protocols, validation plans, summary reports, user requirements ...

Deloitte

System Test and Validation Lead

Dallas, TX · On-site +1

... pharma, biotech, medical device, or clinical * Experience leading validation deliverables for GxP systems, including IQ/OQ/PQ protocols, validation plans, summary reports, user requirements ...

Deloitte

System Test and Validation Lead

Westlake, TX · On-site +1

... pharma, biotech, medical device, or clinical * Experience leading validation deliverables for GxP systems, including IQ/OQ/PQ protocols, validation plans, summary reports, user requirements ...

Deloitte

System Test and Validation Lead

Westlake, TX · On-site +1

... pharma, biotech, medical device, or clinical * Experience leading validation deliverables for GxP systems, including IQ/OQ/PQ protocols, validation plans, summary reports, user requirements ...

Deloitte

System Test and Validation Lead

Houston, TX · On-site +1

... pharma, biotech, medical device, or clinical * Experience leading validation deliverables for GxP systems, including IQ/OQ/PQ protocols, validation plans, summary reports, user requirements ...

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Validation Engineer II - Houston, TX

Unicon Pharma Inc.

Houston, TX • On-site

Contractor

Re-posted 19 days ago

Job description

Description:

Title: Validation Engineer II

Shift: Mon - Fri 5x onsite 1st shift

Job Duties:

  • The Validation Resource for Utilities and Facilities is responsible for ensuring the qualification and validation of critical utility systems and facility infrastructure in a GMP-regulated environment.
  • This includes HVAC systems, water systems (e.g., WFI, RO/DI), cleanrooms, compressed gases, and other support utilities.
  • This resource have to ensure compliance with industry standards and regulatory requirements while working closely with cross-functional teams to support new installations, system upgrades, and operational readiness.

Key Responsibilities:

Commissioning Activities

  • Plan and execute commissioning activities for utility systems (e.g., HVAC, purified water systems, clean steam, compressed gases) and facilities (e.g., cleanrooms, environmental monitoring systems).
  • Troubleshoot and resolve technical issues during the commissioning phase.

Qualification & Validation

  • Author, execute, and review qualification protocols (IQ, OQ, PQ) for utilities and facilities.
  • Validate critical systems, including HVAC balancing, environmental monitoring, water quality testing, and cleanroom certification.
  • Ensure systems meet performance requirements and GMP standards.
  • Perform thermal mapping, pressure testing, and other critical tests as needed.

Documentation

  • Develop and maintain accurate and complete documentation, including protocols, validation reports, and SOPs.
  • Document deviations, CAPAs, and change controls associated with facilities and utilities systems.
  • Ensure traceability of qualification activities in alignment with the Validation Master Plan (VMP).

Compliance and Risk Management

  • Ensure all utility and facility qualification activities meet global regulatory requirements (e.g., FDA, EMA, WHO).
  • Perform risk assessments and develop mitigation strategies for utility and facility systems.
  • Ensure compliance with 21 CFR Part 11, Annex 11, and applicable ISO standards.

Experience

  • 3–5 years of experience in commissioning, qualification, and validation of utilities and facilities in a pharmaceutical, biotech, or regulated manufacturing environment.
  • Hands-on experience with systems such as HVAC, purified water, clean steam, gases, and cleanrooms
  • neat experience
  • Familiarity with environmental monitoring and building management systems (BMS).

Working Conditions

  • Manufacturing plant and utility environments, including cleanrooms.
  • Flexibility to work extended hours or weekends during critical project phases.