Validation Specialist

Katalyst Healthcares and Life Sciences

Albany, NY

Job Description:

We are seeking an experienced Validation Specialist to support validation activities for Syringe Assembly Machines (SAM) in a GMP-compliant pharmaceutical environment. The ideal candidate will possess a strong understanding of the validation lifecycle and documentation required to ensure compliance with industry standards and regulations.

Key Responsibilities:

Perform validation activities for Syringe Assembly Machines, including installation, operational, and performance qualification (IQ, OQ, PQ).
Develop, review, and execute validation protocols and reports in compliance with GMP standards.
Troubleshoot and resolve equipment-related issues during validation activities.
Collaborate with cross-functional teams, including Engineering, Quality Assurance, and Manufacturing, to ensure successful validation.
Maintain detailed and accurate documentation in accordance with regulatory requirements.
Support continuous improvement initiatives to optimize equipment performance and compliance.

Qualifications:

Minimum of 2 years' experience in the validation of Syringe Assembly Machines or equivalent equipment in a GMP pharmaceutical environment.
Solid understanding of Validation Life Cycle documentation, including risk assessments, protocols, and reports.
Familiarity with regulatory standards such as FDA, EU GMP, and ISO guidelines.
Strong analytical, problem-solving, and communication skills.
Ability to work independently and as part of a team to meet project deadlines.

Preferred Qualifications:

Bachelor's degree in Engineering, Life Sciences, or a related field.
Experience with automated manufacturing equipment in sterile environments.
Compensation: Competitive hourly rate based on experience.

Apply

Vacancy posted 4 days ago

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