Validation Engineer (Aseptic C&Q )

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 Recruiter

adarsh.mallik@centstone.com

CENTSTONE SERVICES