Validation Engineer – OSD CQV & Process Excellence

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

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