Senior Validation Engineer

Intellectt Inc; Indiana (PA); On-site; USD 70,000 - 95,000; Full time

Job summary

A leading company in pharmaceutical and biotech sectors is seeking a Validation Engineer skilled in CSV, CQV, and automation to execute validation activities in a GMP-regulated environment. This role demands strong documentation skills and compliance knowledge with regulatory guidelines. Ideal candidates will have a bachelor's degree and substantial industry experience. Competitive salary offered.

Qualifications

• 3+ years’ experience in CSV, CQV, and automation in pharma/biotech.
• Knowledge of regulatory guidelines and automation platforms.
• Strong documentation and communication skills.

Responsibilities

• Execute validation activities for GxP systems.
• Author and execute IQ/OQ/PQ protocols and documentation.
• Ensure compliance with GAMP 5 and regulatory standards.

Skills

CSV

CQV

Automation

Documentation

Communication

Education

Bachelor’s in Engineering, Life Sciences, or related field

Tools

DeltaV

Rockwell

Job description

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Direct message the job poster from Intellectt Inc

Unicorn Recruiter | Tech & Business Talent Specialist | People-First Hiring Partner | Empowering Careers, Enabling Growth @ Intellectt Inc |…

Hello,

One of my clients is currently seeking a Validation Engineer – CSV, CQV & Automation. If this role aligns with your experience or interests, I’d love to connect with you. Please share your updated resume with me at [e-mail], or feel free to call me directly at [phone] to discuss further.

Job Title: Validation Engineer – CSV, CQV & Automation

Location: IN

Duration: 12 Months

Job Summary:

We’re looking for a Validation Engineer with hands-on experience in CSV (Computer System Validation), CQV (Commissioning, Qualification & Validation), and Automation systems within a GMP-regulated environment.

Key Responsibilities:

• Execute validation activities for GxP systems: MES, LIMS, SCADA, PLCs.
• Author and execute IQ/OQ/PQ protocols and validation documentation.
• Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11.
• Handle deviations, CAPAs, and change controls for validated systems.

Qualifications:

• Bachelor’s in Engineering, Life Sciences, or related field.
• 3+ years’ experience in CSV, CQV, and automation in pharma/biotech.
• Knowledge of regulatory guidelines and automation platforms (e.g., DeltaV, Rockwell).
• Strong documentation and communication skills.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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