Validation Engineer

SGS Consulting; Sacramento (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

SGS Consulting is seeking a qualified professional to oversee equipment qualification for QC laboratories. You will coordinate with lab staff to define requirements, author and execute protocols, and ensure documentation meets cGMP and quality standards.

The role emphasizes cross-functional collaboration with vendors and internal teams, maintaining records, and driving continuous improvement in laboratory compliance and efficiency.

Qualifications

• Bachelor's degree in science or related field; experience in pharmaceutical or biopharmaceutical environments preferred.
• Knowledge of current cGMP regulations or equivalent standards.
• Experience authoring, reviewing, and executing equipment qualification documentation.
• Strong understanding of quality and compliance in regulated labs.

Responsibilities

• Perform qualification of QC laboratory equipment per established policies, plans, and procedures.
• Coordinate with laboratory personnel to define equipment qualification requirements and acceptance criteria.
• Author, review, and execute equipment qualification protocols and related documentation.
• Coordinate equipment qualification activities with equipment vendors and internal support organizations.
• Ensure qualification activities comply with current cGMP regulations and applicable quality standards.
• Review qualification documentation for accuracy, completeness, and compliance.

Skills

cGMP Regulations

Equipment Qualification

Equipment Validation

QC Laboratory Validation

Validation Protocols

Protocol Authoring

Protocol Execution

Validation Documentation

Pharmaceutical Manufacturing

Quality Compliance

Quality Systems

Cross-Functional Collaboration

Vendor Coordination

Problem Solving

Project Coordination

Verbal and Written Communication

Education

Bachelor's degree in science

Job description

Job Responsibilities

Perform qualification ofQC laboratory equipmentin accordance withestablishedequipment qualificationpolicies, plans, andprocedures.Coordinate with laboratorypersonnel to defineequipment qualificationrequirements and acceptancecriteria.Author, review, andexecute equipment qualificationprotocols and relateddocumentation.Coordinate equipment qualificationactivities with equipmentvendors and internalsupport organizations.Ensure qualification activitiesare performed incompliance with currentcGMP regulations andapplicable quality standards.Review qualification documentationfor accuracy, completeness, and compliance.Identify business,quality, operational, andcompliance gaps associatedwith laboratory equipmentand qualification activities.Support resolution ofqualification-related issuesand coordinate appropriatecorrective actions.Maintain accurate andtimely validation andqualification records.Signand approve documentationfor activities withinauthorized responsibilitiesand applicable companyprocedures.Work closely withQC laboratory personneland cross-functionalstakeholders toensure equipment isqualified and readyfor intended use.Support continuous improvementinitiatives that enhancelaboratory compliance,operational efficiency,and cost effectiveness.Assist with schedulingand prioritizing qualificationactivities to meetbusiness objectives.Communicate qualificationstatus, issues, risks, and required actionsto appropriate stakeholders.Provide technical andoperational support toQC laboratory activitiesas assigned.Perform additional validation, qualification, and laboratorysupport duties asrequested by management.

Skills

cGMP RegulationsEquipment QualificationEquipment ValidationQC Laboratory ValidationValidation ProtocolsQualification Protocol AuthoringProtocol ExecutionValidation DocumentationPharmaceutical / BiopharmaceuticalManufacturingQuality ComplianceGMP DocumentationQuality SystemsCompliance Gap IdentificationContinuous ImprovementLaboratory EquipmentVendor CoordinationCross-Functional CollaborationTechnical DocumentationProblem SolvingProject CoordinationScheduling and PrioritizationVerbal and WrittenCommunication

Education/Experience

Bachelor's degree (BS/BA), preferably ina relevant scientificdiscipline.Experience in thepharmaceutical or biopharmaceuticalindustry, or anequivalentcombination of educationand experience.Knowledge of currentcGMP regulations orequivalent applicable regulations.Minimum 2 yearsof experience invalidation or equipmentqualification is desired.Experience supporting QClaboratory equipment qualificationactivities preferred.Ability to author, review, execute, andmaintain equipment qualificationdocumentation.Strong understanding ofquality and compliancerequirements in aregulated laboratory environment.Ability to makesound decisions regardingscheduling, priorities, and qualification activities.Flexible approach toproblem-solving andability to providedirection when required.Strong verbal andwritten communication skillswith the abilityto effectively influencestakeholders at differentorganizational levels.Ability tobuild trust-basedand effective workingrelationships with laboratorypersonnel, vendors, andcross-functional teams.Strategic thinking withthe ability totranslate objectives intoactionable plans.Strong ownership, accountability, and results-orientedapproach.