CSV Engineer

Katalyst CRO; Nutley (NJ); Hybrid; USD 80,000 - 100,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking a CSV Engineer to join their team. The ideal candidate will have a strong background in validation processes and experience in the pharmaceutical industry. This hybrid role requires effective communication and the ability to work collaboratively with various stakeholders. The position offers a challenging environment where the candidate can thrive and contribute to critical validation efforts.

Qualifications

• 3-5 years of experience in the pharmaceutical industry or similar.
• 1-3 years of vendor/CSV auditing experience.

Responsibilities

• Conduct thorough reviews of validation documents.
• Assist in the creation and development of validation deliverables.
• Collaborate with the clinical quality assurance systems lead.

Skills

Communication

Time Management

Multi-project Handling

Education

Bachelor's degree in IT

Bachelor's degree in Data Sciences

Job description

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Job Description

We are seeking a versatile professional experienced in Validation, GCP, and CSV, with a solid understanding of the clinical business. The candidate should be capable of meticulously reviewing documents and supporting the creation of validation deliverables. The role requires effective communication of validation processes to stakeholders outside the validation team, thriving in a challenging environment.

Responsibilities

• Conduct thorough reviews of validation documents.
• Assist in the creation and development of validation deliverables.
• Adapt to and excel in a dynamic and challenging work environment.
• Clearly articulate the significance of validation processes to non-specialist audiences.
• Collaborate with the clinical quality assurance systems lead on validation efforts and audits of vendors and computerized systems.
• Participate in computer system and vendor audits, reviewing Quality Management Systems, SDLC, validation, and data integrity controls.
• Review CAPA and verify CAPAs from system and vendor audits.
• Serve as QA approver for internal validation efforts.
• Act as a liaison to the business for guidance on software validation.
• Support health authority audits/inspections for inspection readiness.

Requirements

• Bachelor's degree in IT, Data Sciences, or related fields.
• Familiarity with software development methodologies such as Agile and Waterfall.
• 3-5 years of experience in the pharmaceutical industry or similar.
• 1-3 years of vendor/CSV auditing experience.
• Knowledge of software validation regulations.
• Knowledge of GCP/GMP is preferred.
• Strong communication, independent time management, and multi-project handling skills.
• Ability to travel.

Note

• Hybrid role; must be a local candidate willing to work onsite 2-3 days a week in Nutley.

Additional Details

• Seniority level: Associate
• Employment type: Contract
• Industry: Pharmaceutical Manufacturing