Smithfield Foods

3 weeks ago

Laboratory Systems and Validation Manager

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 3 hours agoStatus: Live

Job Summary

Lead technical operations for QC laboratory systems and validation, ensuring compliance with cGMP and SOPs and supporting FDA expectations. Own qualification of testing equipment and software validation for laboratory data systems, including data integrity and documentation practices aligned to 21 CFR Part 11 and EU Annex 11 (with GAMP 5). Manage cross-functional technical work, support OOS investigations, and provide leadership through training, coaching, and mentoring.

Location: Cincinnati

Workplace: Onsite

Employment Type: Full time

Job Function: Laboratory & Clinical Operations

Seniority: Manager level

Key Responsibilities

•Own qualification of testing equipment and software validation for laboratory data systems to ensure data integrity and regulatory compliance (21 CFR Part 11, EU Annex 11, and GAMP 5).
•Manage system administration for QC software systems, including data backup and validated system lifecycle oversight.
•Validate/verify quality control methods to ensure APIs are tested and manufactured in accordance with cGMP, SOPs, and safety requirements.
•Lead commissioning and qualification work, including analytical method optimization, transfer, and method validation/verification; drive product lifecycle improvement projects.
•Provide leadership to cross-functional teams and support OOS investigations with root-cause analysis and CAPA to prevent recurrence.

Pay and Benefits

Salary: USD 120,000 - 162,500 annually

Perks:Relocation

Key Requirements

•Bachelor’s degree in chemistry, microbiology, or another technical field plus 5+ years’ experience in an FDA cGMP-compliant QC laboratory environment.
•2+ years of experience in team management/development or project leadership.
•Demonstrated leadership skills with ability to uphold regulatory, company, and customer standards.
•Proficiency with complex mathematical calculations and technical writing plus strong written and verbal communication.
•Ability to structure work plans, manage multiple priorities, and organize employees in a fast-paced environment.

Experience:5+ yearsFDA cGMPQC laboratory

Education:Bachelor's in Chemistry, microbiology or other technical field

Skills:LeadershipTechnical writingCommunicationOrganizational skillsWork planning

Tech Stack:21 CFR Part 11EU Annex 11GAMP 5CGMPFDALaboratory data systemsQC software systems

Company Brief

Smithfield Foods

Produces pork and packaged meat products, operating integrated hog production, processing, and branded food businesses. It supplies retail, foodservice, and export markets across the United States and internationally.

Industry: Food Production

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Established Company

Headquarters: Smithfield, United States

Founded: 1936

Website LinkedIn

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Smithfield Foods

3 weeks ago

Laboratory Systems and Validation Manager

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 3 hours agoStatus: Live

Job Summary

Location: Cincinnati

Workplace: Onsite

Employment Type: Full time

Job Function: Laboratory & Clinical Operations

Seniority: Manager level

Key Responsibilities

•Own qualification of testing equipment and software validation for laboratory data systems to ensure data integrity and regulatory compliance (21 CFR Part 11, EU Annex 11, and GAMP 5).
•Manage system administration for QC software systems, including data backup and validated system lifecycle oversight.
•Validate/verify quality control methods to ensure APIs are tested and manufactured in accordance with cGMP, SOPs, and safety requirements.
•Lead commissioning and qualification work, including analytical method optimization, transfer, and method validation/verification; drive product lifecycle improvement projects.
•Provide leadership to cross-functional teams and support OOS investigations with root-cause analysis and CAPA to prevent recurrence.

Pay and Benefits

Salary: USD 120,000 - 162,500 annually

Perks:Relocation

Key Requirements

•Bachelor’s degree in chemistry, microbiology, or another technical field plus 5+ years’ experience in an FDA cGMP-compliant QC laboratory environment.
•2+ years of experience in team management/development or project leadership.
•Demonstrated leadership skills with ability to uphold regulatory, company, and customer standards.
•Proficiency with complex mathematical calculations and technical writing plus strong written and verbal communication.
•Ability to structure work plans, manage multiple priorities, and organize employees in a fast-paced environment.

Experience:5+ yearsFDA cGMPQC laboratory

Education:Bachelor's in Chemistry, microbiology or other technical field

Skills:LeadershipTechnical writingCommunicationOrganizational skillsWork planning

Tech Stack:21 CFR Part 11EU Annex 11GAMP 5CGMPFDALaboratory data systemsQC software systems

Company Brief

Smithfield Foods

Industry: Food Production

Company Size: Enterprise (1,001+ employees)

Revenue: USD 1B+

Growth: Established Company

Headquarters: Smithfield, United States

Founded: 1936

Website LinkedIn