Validation Engineer Senior (CQV - Pharmaceutical)

Aditi Consulting; Thousand Oaks (CA); On-site; USD 125,000 - 150,000; Full time

Job summary

An established industry player is seeking a Validation Engineer Senior to join their Quality Assurance team. This role involves planning and executing commissioning and qualification actions in a pharmaceutical environment, ensuring compliance with cGMP guidelines. You will work closely with project teams to develop strategies and document protocols for GMP utilities and process equipment. The ideal candidate will possess a strong educational background in a technical field and relevant experience in a pharmaceutical organization. This is a fantastic opportunity to contribute to critical projects while enjoying a comprehensive benefits package.

Benefits

Medical Benefits

Dental Benefits

Vision Benefits

401(k) Plan Participation

10 Paid Days Off

Commuter Benefits

Life Insurance

Disability Insurance

Qualifications

• Degree in a technical or natural scientific field is essential.
• Experience in a pharma organization within a C&Q/CQV role is required.

Responsibilities

• Plan and track implementation of commissioning & qualification actions.
• Author and evaluate qualification/validation protocols for GMP utilities.

Skills

Analytical Thinking

Effective Communication

Knowledge of cGMP Guidelines

Project Management

Quality Assurance Principles

Education

Degree in Technical or Natural Science

Tools

Kneat Gx Platform

Job description

Join to apply for the Validation Engineer Senior (CQV - Pharmaceutical) role at Aditi Consulting.

This range is provided by Aditi Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$60.00/hr - $62.00/hr

Responsibilities:

• Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines.
• Work with project teams to develop the commissioning and qualification strategy and document in qualification plans.
• Author/evaluate qualification/validation protocols including DQ, IQ, OQ, FT, PQ protocols and final reports for new or modified GMP utilities, facilities, and process equipment.
• Execute DQ, IQ, OQ, FT, PQ protocols, which involve protocol discrepancies, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipment.
• Ensure that Qualification/Validation plans are generated and updated for all ongoing projects.
• Prepare, evaluate and approve technical and GMP linked documentation such as URS, FMEA, impact/risk assessment, master plans, qualification/validation documentation.
• Arrange and implement FAT/SAT, commissioning activities for new GMP systems in collaboration with both internal and external partners.
• Other duties may be assigned to this role.

Key Skills and Requirements:

• Educated to a degree level in a technical or natural scientific field.
• Demonstrable experience in a pharma organization within a C&Q/CQV corresponding role.
• Knowledge of qualification needs to cGMP guidelines.
• Familiarity with Kneat Gx Platform or other digital C&Q systems.
• Familiarity working with cross-department stakeholders.
• Knowledge of quality assurance principles.
• Experience working within project teams and various projects in parallel.
• Prior involvement working with ISPE baseline guide vol 3, vol 4 and vol 5 would be beneficial.
• Effective communication skills, both verbally and in writing.
• Able to think analytically with the ability to resolve issues.
• Able to manage your own time efficiently.

Pay Transparency: The typical base pay for this role across the U.S. is: $60.00 - $62.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
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Seniority level

Entry level

Employment type

Contract

Job function

Quality Assurance