Validation Engineer

Spectraforce Technologies; Carlsbad (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Spectraforce Technologies is seeking a Validation Engineer for on-site work in Carlsbad, CA to develop and implement the division validation program and maintain validation documentation for systems and processes under design control.

The role requires 2–3 years of experience in a quality system environment, with a Bachelor’s degree (Master’s preferred). You will participate in audits, manage validation protocols and VMPs, and collaborate with owner/user groups to produce final reports.

Qualifications

• Bachelor’s degree in a related field; Master’s degree preferred.
• Experience in validation activities or quality systems environment.
• Understanding of regulatory requirements and design control.
• Ability to communicate and document clearly.

Responsibilities

• Represent Division during internal and external audits of validation projects and documentation.
• Write validation documentation against production processes and systems in compliance with internal and external requirements.
• Manage execution of validation protocols as protocol director to ensure timely, cost-efficient completion.
• Evaluate validation results of protocol executions using technical and regulatory skills.
• Consult with owner/user groups to summarize validation results in final reports with clear communication.

Education

Bachelor’s Degree

Master’s Degree

Job description

Position Title: Validation Engineer

Work Location: Carlsbad, CA 92008

Assignment Duration: 09 Months

Work Arrangement: On-site

Shift: 8 AM to 5 PM

Main purpose of the role

Responsible for creating and implementing the Division validation program. Creates and maintains validation documentation for new and existing systems and processes subject to design control. Ensures that validation activities are implemented for systems and processes used to manufacture, control and store intermediates and finished products to requirements and standards as listed in the current Quality Systems Manual.

Main Responsibilities

• Represent Division during internal and external audits of validation projects and documentation.
• Write validation documentation against production processes and systems in compliance to internal and external requirements utilizing well developed technical and regulatory skills.
• Manage the execution of validation protocols, as protocol directors, in assurance of timely and cost efficient completion through specialized experience and training.
• Evaluate validation results of validation protocol executions employing specialized experience and training.
• Consult with owner/user groups to summarize validation results in final reports incorporating strong communication skills and experience.
• Manage Validation Master Plans (VMPs) and associated reports related to new product development and existing production processes, systems, and controls.
• Perform validation assessment on Change Management documentation including, but not limited to document changes, system changes, and process changes.
• Track and report validation progress of corporate validation projects through departmental project tracking tools.
• Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks.
• May lead a project team of moderate scope.
• Provides guidance to less experienced staff.
• Acts as a mentor to lower level individual contributors.
• Influence exerted at peer level and occasionally at first levels of management.
• Plans, organizes, and prioritizes own daily work routine to meet established schedule.
• Exercises authority and judgment within defined limits to determine appropriate action.
• Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.

Qualifications

• Education: Bachelor’s Degree in related field. Master’s Degree preferred.

Experience / Background Details

• Minimum 2-3 years of related work experience with a good understanding of specified functional area.
• Working technical knowledge and application of concepts, practices and procedures.
• General understanding of business unit/group function.
• Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.