Laboratory Systems and Validation Manager

Smithfield Bioscience, Inc; Cincinnati (OH); On-site; USD 105,000 - 140,000; Full time

Benefits offered by this job

Relocation package

Job summary

Smithfield Foods, Inc. is seeking an experienced QC lead to manage the technical operations for quality control of our products, ensuring cGMP compliance and data integrity across laboratory systems.

The role reports to the Senior Manager of Quality Control and involves leading equipment qualification, software validation, and cross-functional collaboration with Engineering, QA, Manufacturing and R&D. You will champion GMPs, safety, and GDP, oversee the software development lifecycle for

Qualifications

• Bachelor’s degree in a chemistry, microbiology or related technical field.
• 5+ years of demonstrated experience in FDA cGMP in a QC laboratory.
• 2+ years of demonstrated experience in team management or project leadership.
• Strong written and verbal communication skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Ability to work cross-functionally with Engineering, QA, Manufacturing, and R&D.

Responsibilities

• Qualification of testing equipment.
• Software validation of laboratory data systems to ensure data integrity and compliance with 21CFR Part 11 and EU Annex 11.
• System administration for QC software systems, including data backup.
• Validation/verification of QC methods to ensure API testing and manufacturing in accordance with cGMP, SOPs, and safety requirements.
• Lead commissioning and qualification of laboratory equipment and software validation; analytical method optimization, transfer and validation/verification; and product lifecycle improvement projects.
• Provide leadership for cross-functional teams, including training, coaching, and mentoring.
• Champion cGMPs, safety, and workplace activities and help develop and meet QC compliance and safety goals.
• Respond to observed laboratory or safety issues and take action as appropriate.
• Work closely with Engineering/Maintenance, Quality Assurance, Manufacturing and R&D teams.
• Support QC out-of-specification (OOS) investigations and CAPA to determine product impact, root causes and preventive actions.
• Provide technical expertise to resolve equipment, software or testing issues and interact with colleagues to ensure QC testing requirements are met.
• Draft, revise and review technical protocols, reports, SOPs, and worksheets, ensuring compliance with cGMP and GDP.
• Timely and compliant oversight of the software development lifecycle for validated systems.
• Ensure QC metrics and business systems records are properly developed and maintained.
• Counsel employees to promote their success and manage performance issues.

Skills

Team management

Project leadership

cGMP compliance

Written & verbal communication

Cross-functional collaboration

Problem solving under pressure

Education

Bachelor’s degree in chemistry, microbiology, or related field

Job description

If you are currently employed at Smithfield, please log into Workday and submit your application through the Jobs Hub. Have a seat at our table. When you join Smithfield, you become part of something special – a company that’s sustainably feeding people around the world, producing good food the right way with respect for our people, animals, communities and planet. With opportunities across locations and functions, a culture grounded in our Core Four values - gratitude, communication, respect and accountability - and a strong commitment to learning, collaboration, and innovation, Smithfield offers challenging and rewarding careers where you can grow, contribute and make a real impact.

Your Opportunity

This is a full-time position reporting to the Senior Manager of Quality Control. The position is one of leading the technical operations related to quality control of the Company’s products pursuant to Standard Operating Procedures (SOPs) and in compliance with current Good Manufacturing Practice (cGMP) as required by the U.S. Food and Drug Administration (FDA).

• Responsible for qualification of testing equipment
• Software validation of laboratory data systems to ensure data integrity and compliance with 21CFR Part 11 and EU Annex 11 requirements as well as GAMP 5 guidelines.
• Responsible for system administration functions for QC software systems, including data backup.
• Validation/verification of quality control methods to ensure active pharmaceutical ingredients are tested and manufactured in accordance with cGMP, SOPs, and safety requirements.
• Lead and assign technical tasks/duties associated with commissioning and qualification of laboratory equipment and software validation; analytical method optimization, transfer and validation / verification; and product lifecycle improvement projects.
• Provide leadership for cross-functional teams, including training, coaching, and mentoring.
• Champion cGMPs, safety, and workplace activities and help develop and meet QC compliance and safety goals.
• Respond to any observed laboratory or safety issues and take action as appropriate.
• Work closely with Engineering/Maintenance, Quality Assurance, Manufacturing and R&D teams.
• Support QC out-of-specification (OOS) investigations as needed to determine product impact, root causes and identify corrective and preventive actions (CAPA) to prevent recurrence.
• Provide technical expertise to resolve equipment, software or testing issues and interact with colleagues to ensure QC testing requirements are met.
• Draft, revise and review technical protocols, reports, standard operating procedures, and worksheets, ensuring compliance with cGMP and Good Documentation Practices (GDP).
• Timely and compliant oversight of the software development lifecycle for validated systems.
• Ensure QC metrics and business systems records are properly developed and maintained.
• Counsel employees to promote their success and manage employee performance issues as needed.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. May perform other duties as assigned.

Qualifications

• Bachelor’s degree from an accredited four-year college or university in a chemistry, microbiology or other technical field and 5+ years of demonstrated experience in FDA cGMP compliance environment in a QC laboratory.
• 2+ years of demonstrated experience in team management/development or project leadership is required
• Demonstrated leadership skills and the ability to uphold regulatory, company, and customer standards.
• Proficient with complex mathematical calculations, technical writing, interpersonal and communication skills (written and verbal).
• Ability to structure work plans and organize employees to achieve results with demonstrated ability to manage multiple priorities in a fast-paced environment.
• Capable of working well with cross-functional teams in a dynamic setting to achieve company goals.
• Works well in high pressure situations.

The expected pay range for this position is $105,000 - $140,000 annually. Smithfield Foods provides pay ranges that reflect its good faith estimate of the salary or hourly wage the company reasonably expects to pay for a position at the time of hire. Individual compensation will be determined based on several factors, including but not limited to, the scope and responsibilities of the role, location of the position, the candidate’s qualifications and experience, internal equity, external market pay for comparable positions and budget considerations. At Smithfield Foods, base pay represents only one aspect of the comprehensive total rewards package. Learn more about our benefits package here.

Relocation Package Available Yes

EEO Information

Smithfield is an equal opportunity employer committed to workplace diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, gender identity, protected veterans status, status as a disabled individual or any other protected group status or non-job characteristic as directed by law. If you are an individual with a disability and would like to request a reasonable accommodation for any part of the employment selection process, please call us at 757-357-1595.

At Smithfield, good food starts with good people. 'Good food. Responsibly.' is more than just our tagline; it's what we do. We provide good jobs. We take good care of our animals. We are good stewards of the environment. We do good in our local communities. Smithfield is proud to offer robust, flexible and affordable benefit plans and programs to support our team members and their loved ones, and with out-of-pocket costs, on average, 20 percent less than plans offered by other employers. Beyond our medical plans, our Be Well programs offer tools and resources to enhance your quality of life, at no additional cost. These programs are uniquely tailored to our Smithfield team and provide support for elective surgeries, weight loss, mental health, cancer, kidney disease, diabetes, smoking cessation, asthma, maternity management and more. Our company invests in your future. We offer comprehensive training and professional development programs designed to help you reach your full potential. Through LinkedIn Learning, employees can access on‑demand courses, professional certificates, and skill‑based training to build capabilities aligned with career and business needs. Our partnership with Guild supports your continuing education with tuition assistance covering English language learning, high school completion, and degree programs, while our leadership development initiatives nurture high‑potential talent. We also offer unique benefits like our Smithfield Scholarship Program for employees’ children.

Headquartered in Smithfield, Virginia, since 1936, Smithfield Foods, Inc. is an American food company with a leading position in packaged meats and fresh pork products. With a diverse brand portfolio and strong relationships with U.S. farmers and customers, we responsibly meet demand for quality protein around the world. For more information, visit www.smithfieldfoods.com. We believe in the power of protein to end food insecurity and have donated hundreds of millions of food servings to our communities. Smithfield boasts a portfolio of high-quality iconic brands, such as Smithfield, Eckrich and Nathan's Famous, among many others. For more information, visit www.smithfieldfoods.com and connect with us on Facebook, X, formerly known as Twitter, LinkedIn, and Instagram.