Validation Engineer

Stark Pharma Solutions Inc; Columbus (OH); On-site; USD 90,000 - 110,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking a seasoned Validation Engineer to support Oral Solid Dosage manufacturing under a cGMP framework in Ohio.

The role concentrates on Process Validation, Cleaning Validation, and CQV activities across equipment, facilities, utilities, and processes used in OSd manufacturing. The ideal candidate has hands-on IQ/OQ/PQ/PPQ experience, swab and rinse sampling expertise, and a solid understanding of FDA/EMA requirements, with strong technical writing and

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• Experience as a Validation Engineer in a pharmaceutical manufacturing environment.
• Experience with OSD manufacturing processes.
• Hands-on experience with Process Validation and Cleaning Validation.
• Experience with CQV and equipment qualification.
• Strong knowledge of IQ/OQ/PQ and PPQ.
• Experience with swab and rinse sampling and residue limit calculations.
• Knowledge of cGMP, FDA, and EMA requirements.
• Strong technical writing, communication, and problem-solving skills.

Responsibilities

• Support Process Validation, Cleaning Validation, and CQV activities.
• Prepare, review, and execute IQ/OQ/PQ and PPQ protocols.
• Prepare validation plans, protocols, and final reports.
• Support qualification of manufacturing equipment, facilities, and utilities.
• Support cleaning validation activities, including swab and rinse sampling.
• Perform residue limit calculations for cleaning validation.
• Support equipment installation, process improvements, and technology transfers.
• Work with Manufacturing, Quality Assurance, Engineering, MS&T, and Regulatory teams.
• Ensure validation activities comply with cGMP, FDA, and EMA requirements.
• Support OSD manufacturing processes including blending, granulation, compression, encapsulation, coating, and packaging.

Skills

Validation Engineering

Process Validation

Cleaning Validation

CQV

IQ/OQ/PQ

PPQ

Residue calculations

cGMP/FDA/EMA knowledge

Technical writing

Education

Bachelor's degree in Engineering/Life Sciences

Job description

About the Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India.

We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: Validation Engineer
Location: Ohio
Duration: Long Term

Job Overview

We are seeking an experienced Validation Engineer to support Oral Solid Dosage (OSD) manufacturing operations within a cGMP pharmaceutical environment.

The role will focus on Process Validation, Cleaning Validation, and CQV activities for pharmaceutical manufacturing equipment, facilities, utilities, and processes.

Key Responsibilities

• Support Process Validation, Cleaning Validation, and CQV activities.
• Prepare, review, and execute IQ/OQ/PQ and PPQ protocols.
• Prepare validation plans, protocols, and final reports.
• Support qualification of manufacturing equipment, facilities, and utilities.
• Support cleaning validation activities, including swab and rinse sampling.
• Perform residue limit calculations for cleaning validation.
• Support equipment installation, process improvements, and technology transfers.
• Work with Manufacturing, Quality Assurance, Engineering, MS&T, and Regulatory teams.
• Ensure validation activities comply with cGMP, FDA, and EMA requirements.
• Support OSD manufacturing processes including blending, granulation, compression, encapsulation, coating, and packaging.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• Experience as a Validation Engineer in a pharmaceutical manufacturing environment.
• Experience with OSD manufacturing processes.
• Hands-on experience with Process Validation and Cleaning Validation.
• Experience with CQV and equipment qualification.
• Strong knowledge of IQ/OQ/PQ and PPQ.
• Experience with swab and rinse sampling and residue limit calculations.
• Knowledge of cGMP, FDA, and EMA requirements.
• Strong technical writing, communication, and problem-solving skills.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.