Validation Engineer

Stark Pharma Solutions Inc; Columbus (OH); On-site; USD 80,000 - 110,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking an experienced Validation Engineer to support Oral Solid Dosage (OSD) manufacturing operations within a cGMP pharmaceutical environment.

Responsibilities include overseeing process validation, cleaning validation, and CQV activities for equipment, facilities, utilities, and processes. The ideal candidate has hands-on experience with IQ/OQ/PQ/PPQ, swab and rinse sampling, residue calculations, and equipment qualification, and demonstrates strong technical

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or 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

Process Validation

Cleaning Validation

CQV

IQ/OQ/PQ/PPQ

Residue calculations

Equipment qualification

Swab & rinse sampling

Technical writing

Regulatory knowledge

Education

Bachelor's degree in Engineering or 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.

Equal Opportunity Statement

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