Validation Engineer

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

Job summary

Join a forward-thinking company as a Validation Engineer, where you'll be integral in ensuring compliance with cGMP guidelines. In this role, you'll author and evaluate critical qualification protocols, manage project timelines, and collaborate with cross-department stakeholders. This position offers an opportunity to work on innovative projects in the pharmaceutical manufacturing sector, ensuring the highest quality standards are met. If you're ready to make a significant impact and thrive in a dynamic environment, this role is perfect for you.

Qualifications

• Experience in pharma organization within C&Q/CQV role.
• Knowledge of qualification needs to cGMP guidelines.

Responsibilities

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

Skills

cGMP Guidelines

Analytical Thinking

Communication Skills

Project Management

Quality Assurance Principles

Cross-Department Collaboration

Education

Degree in Technical or Natural Science

Tools

Kneat Gx Platform

Job description

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

Base pay range

$50.00/hr - $54.00/hr

Direct message the job poster from ACL Digital

• Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines.

• 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 own time efficiently.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Industries

  Pharmaceutical Manufacturing

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