Validation Engineer (Aseptic C&Q )

Birmingham, MI - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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

Bachelors 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

CENTSTONE SERVICES

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 ...

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

Bachelors 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.