Validation Engineer

Location: Carlsbad, CA



Contract Duration: 6 Months



Hours: 40 Hours/Week



Rate: Up to $50 $51/hr on C2C, based on experience



Client: Abbott



Visa Status: Must be included with candidate submission Position Overview

We are seeking an experienced Validation Engineer to support Abbott's validation program in Carlsbad, CA. The Validation Engineer will be responsible for developing and executing validation strategies and maintaining validation documentation for new and existing systems and processes subject to design control.

The ideal candidate will have experience with GMP facilities, utilities, process equipment, analytical instruments, laboratory systems, equipment qualification, process validation, and risk-based validation methodologies within a regulated pharmaceutical, biotechnology, or medical device environment.

• Develop and execute validation strategies for GMP facilities, utilities, process equipment, analytical instruments, and laboratory systems.

• Author and execute Validation Master Plans (VMPs) , equipment validation plans, and qualification strategies using risk-based approaches.

• Manage VMPs and associated validation reports for new product development and existing production processes, systems, and controls.

• Develop and/or review:

  • User Requirements Specifications (URS)

  • Functional Requirements

  • Risk Assessments

  • Requirements Traceability Matrices (RTMs)

• Author protocols for:

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Engineering Study Protocols (ESPs)

  • Process Validation

  • Facilities, Utilities, Equipment, and Instrument Qualification

• Lead or support execution of IQ/OQ/PQ, Test Method Validation (TMV), Engineering Studies, and Process Validation activities.

• Manage validation protocol execution to ensure timely, cost-effective completion.

• Evaluate validation execution results and identify potential issues or gaps.

• Work with equipment owners and user groups to summarize validation results and prepare final reports.

• Support equipment commissioning, installation verification, startup, and turnover into GMP operations.

• Perform validation assessments of Change Management documentation, including document, system, and process changes.

• Track and report validation project progress using departmental project tracking tools.

• Evaluate qualification and validation results and investigate deviations and validation events.

• Author Validation Event Reports (VERFs) and support implementation of corrective actions.

• Represent the Abbott division during internal and external audits related to validation projects and documentation.

• Present validation status, qualification results, and release recommendations during project reviews.

• Collaborate with internal teams, equipment vendors, and external resources to complete validation activities.

• May lead projects of moderate scope and provide technical guidance to less experienced engineers.

• Mentor junior-level team members and contribute to knowledge-sharing activities.

• Plan, organize, and prioritize daily activities to meet established project schedules.

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.

• Master's degree is preferred.

• 2 3+ years of relevant validation/qualification experience in a regulated industry.

• Strong understanding of validation principles, practices, and procedures.

• Experience working in a GMP and quality-system environment .

• Working knowledge of applicable regulatory requirements and industry standards.

• Ability to independently analyze technical problems and determine appropriate solutions.

• Strong written and verbal communication skills.

• Ability to work cross-functionally with engineering, manufacturing, quality, laboratory, and project teams.

Candidates with experience in one or more of the following areas are strongly preferred:

• Qualification and validation of GMP manufacturing equipment used in:

  • Oligonucleotide manufacturing

  • Biologics

  • Biotechnology

  • Pharmaceutical manufacturing

• Hands-on validation leadership for analytical instrumentation, including:

  • Agilent HPLC

  • OpenLab CDS

  • Chromatography Data Systems

  • Spectrophotometers

  • Other laboratory analytical equipment

• Experience qualifying automated purification systems, including:

  • Cytiva KTA Pure

  • KTA Go

  • KTA Flux

  • Tangential Flow Filtration (TFF)

  • Chromatography systems utilizing UNICORN

• Experience with oligonucleotide synthesis equipment such as Cytiva KTA OligoSynt or similar automated synthesis platforms.

• Experience independently planning and leading Commissioning, Qualification, and GMP Readiness activities for:

  • Manufacturing facilities

  • Cleanrooms

  • Laboratories

  • Utilities

  • Process equipment

  • Infrastructure systems

• Strong experience developing and executing lifecycle validation documentation, including:

  • Validation Master Plans (VMPs)

  • URS

  • RTMs

  • Risk Assessments

  • IQ/OQ/PQ Protocols

  • Engineering Studies

  • Process Validation Protocols

  • Validation Reports

  • Final Validation Turnover Packages

• Experience managing the complete validation lifecycle from commissioning and qualification through:

  • Equipment release

  • Process validation

  • Change control

  • Deviation investigations

  • Maintaining validated state

• Experience working directly with equipment vendors during commissioning and qualification.

• Ability to review vendor documentation and develop wrapper protocols aligned with site qualification standards and Quality Management System requirements.

• This position operates within a regulated quality-system and GMP environment .

• Strong attention to documentation, compliance, traceability, and data integrity is required.

• Errors or failure to properly execute validation activities may result in regulatory noncompliance, project delays, or additional resource requirements.

• The role requires sound judgment within established procedures and practices.

• Candidates should be comfortable working on projects involving moderate technical complexity and multiple cross-functional stakeholders.

Please include the following with every candidate submission:

• Candidate Resume

• Visa Status

• LinkedIn Profile

• Current Location

• Availability

• Rate Confirmation

• Relevant Validation/GMP Experience

• Contact Information

Max C2C Rate: $51/hr, depending on experience.

Please submit qualified candidates ASAP.