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Evotec

Automation CSV Engineer

Evotec

Automation CSV Engineer responsible for validation, compliance, and technical documentation for GMP automation systems. Collaborating with cross-functional teams in a regulated manufacturing environment.

Posted 7/28/2026full-timeRedmond • Washington • 🇺🇸 United StatesMid-LevelSenior💰 $115,000 - $126,500 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in supporting GMP automation systems, including validation, compliance, and technical documentation, while ensuring adherence to GxP regulations and industry standards. Proficient in executing validation activities and managing automation system lifecycles within regulated environments.

Highest-signal resume keywords
GMP Automation Systems SupportComputer System Validation (CSV)Validation Testing Activities (FAT, SAT, IQ, OQ, PQ)Technical Writing for Validation DocumentationGxP Regulations Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
GMP Automation SystemsComputer System Validation (CSV)Validation Testing (FAT, SAT, IQ, OQ, PQ)Technical WritingAutomation Platforms (DeltaV, PI, SCADA, PLC)Lifecycle ManagementChange ControlRisk AssessmentDeviation ManagementCAPA Support
Soft Skills
Organizational SkillsAttention to DetailEffective CommunicationCollaboration Skills
Industry Keywords
GxP Regulations21 CFR Part 11Annex 11GAMP 5FDA CSA PrinciplesData IntegrityPharmaceutical Quality Systems

About the role

Key responsibilities & impact
  • The Automation CSV Engineer is responsible for supporting validation, compliance, testing, and technical documentation activities for GMP automation systems within a regulated manufacturing environment.
  • Support validation and lifecycle management activities for GMP automation systems including DeltaV, PI, SCADA, PLC, and associated manufacturing control platforms.
  • Assist in ensuring automation systems remain compliant with GxP regulations, internal procedures, and industry standards throughout the system lifecycle.
  • Participate in implementation, upgrade, patching, migration, and change control activities for automation systems.
  • Execute and support commissioning, qualification, and validation testing activities including FAT, SAT, IQ, OQ, PQ, and automation functional testing.
  • Document test execution results, discrepancies, deviations, and corrective actions in accordance with approved procedures.
  • Collaborate with system owners and technical SMEs to gather system requirements and support risk assessments for automation systems.
  • Support periodic reviews, audit readiness activities, and inspection support for validated automation systems.

Requirements

What you’ll need
  • Bachelor’s degree in Engineering, Computer Science, Biotechnology, Information Systems, or related technical discipline preferred.
  • Minimum of 5 years of experience supporting GMP automation systems, computer system validation (CSV), automation testing, or technical writing activities within regulated industries.
  • Hands-on experience with automation platforms such as DeltaV, PI, SCADA, PLC, or related manufacturing systems.
  • Experience executing validation and qualification activities including FAT, SAT, IQ, OQ, PQ, and functional testing.
  • Strong technical writing skills with experience authoring validation documentation and compliance records.
  • Working knowledge of GxP regulations and industry guidance including: 21 CFR Part 11, Annex 11, GAMP 5, FDA CSA principles, Data Integrity requirements.
  • Understanding of automation system lifecycle management and pharmaceutical quality systems.
  • Experience supporting change controls, deviations, CAPAs, and risk assessments within GMP environments.
  • Strong organizational skills and attention to detail with the ability to manage multiple assignments simultaneously.
  • Effective communication and collaboration skills with the ability to work across technical and business functions.

Benefits

Comp & perks
  • discretionary annual bonus
  • comprehensive benefits to include Medical, Dental and Vision
  • short-term and long-term disability
  • company paid basic life insurance
  • 401k company match
  • flexible work
  • generous paid time off
  • paid holiday
  • wellness and transportation benefits