Validation Engineer (Aseptic C&Q )

Job Description

Job Description

Job Title: Validation Engineer (Aseptic C&Q )
Openings: 1
Location: Birmingham, AL (Onsite)
Start: January 2026
Duration: Minimum 6 months (extendable)
Employment Type: Contract

Job Summary
We are seeking a Validation Engineer with strong experience in aseptic pharmaceutical validation and equipment qualification. The ideal candidate will have hands-on expertise in C&Q activities, documentation, and compliance aligned with FDA/EU/GMP standards. This role will support new and existing aseptic facilities and critical manufacturing systems.

Key Responsibilities

• Develop and maintain validation/qualification documentation for aseptic facilities and equipment.

• Create and execute C&Q deliverables including URS, risk assessments, commissioning plans, IQ/OQ/PQ protocols, and final reports.

• Perform Commissioning (COM), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.

• Ensure all validation documentation meets internal quality standards and regulatory expectations (FDA/EU/GMP).

• Conduct risk assessments and define mitigation strategies for aseptic processes and systems.

• Collaborate cross-functionally with Engineering, Quality, Manufacturing, and other stakeholders to meet project timelines.

• Support requalification and lifecycle management activities for validated systems and equipment.

• Lead or support Computer System Validation (CSV) activities, including system classification, test script creation/execution, and compliance reporting.

• Verify system functionality and data integrity consistent with regulatory requirements.

Required Qualifications

• Bachelor’s degree in Engineering or Science (preferred).

• 3–5 years of experience in validation/qualification of aseptic pharmaceutical processes and/or equipment.

• Strong knowledge of FDA/EU regulatory frameworks, GMPs, and industry best practices.

• Demonstrated experience authoring and executing URS, protocols, and validation reports.

• Strong understanding of pharmaceutical manufacturing equipment and process validation.

• Proficiency with documentation tools and Microsoft Office (Word, Excel, PowerPoint).

• Excellent communication, organization, and stakeholder management skills.

• Ability to work independently and within cross-functional teams.

Preferred/Tools & Equipment Exposure

• Experience with Kaye Validator AVS and ValProbe systems.

• Knowledge of qualification for equipment such as:

  • Homogenizers

  • Pump skids

  • SIP/CIP skids

  • Temperature control units (CTUs)

  • Tanks and related utilities

• Experience supporting aseptic facility start-ups, expansions, or technology transfers.
  
  

Thanks & Regards,

Adarsh Mallik | IT Recruiteradarsh.mallik@centstone.comCENTSTONE SERVICES