What are the responsibilities and job description for the Sr Validation Engineer position at Sterling Engineering?
Title: Cleaning Validation Engineer
Location:Crystal Lake IL
Hire Type: Direct
Shift : 1st
Compensation:$95,000-105,000
Benefits: eligible to receive a Full Employee Benefits Package that includes paid time off, paid holidays,.
Position Overview
The Cleaning Validation Engineer is responsible for the planning, execution, documentation, and lifecycle support of cleaning validation activities for manufacturing equipment, processes, and associated systems in a GMP-regulated pharmaceutical environment. This role ensures cleaning processes are scientifically sound, compliant with regulatory requirements, and capable of consistently meeting established acceptance criteria.
The engineer will develop and execute validation protocols, assess results, prepare final reports, and support change controls related to equipment, processes, and cleaning procedures. This position works closely with Manufacturing, Engineering, Quality Assurance, Quality Control, and Regulatory teams to ensure validated cleaning programs protect product quality and patient safety. The role also supports inspections, continuous improvement initiatives, and the development of validation procedures, SOPs, and quality standards.
Key Responsibilities
Serve as the validation representative on cross-functional project teams related to cleaning processes and equipment.
Lead and manage cleaning validation activities for new equipment, existing equipment changes, and process improvements.
Develop scientifically sound cleaning validation protocols with defined acceptance criteria, sampling plans, and assessment methods.
Coordinate and schedule execution of cleaning validation studies with Manufacturing, Quality, and Engineering teams.
Author, execute, and close cleaning validation studies and reports in support of equipment and process change controls.
Evaluate cleaning validation data to confirm repeatability, effectiveness, and compliance with internal procedures and regulatory expectations.
Prepare clear, thorough documentation packages summarizing study execution, results, deviations, conclusions, and recommendations.
Partner with Quality Control and Quality Assurance on sample strategies, residue limits, recovery studies, and acceptance criteria.
Maintain close communication with Manufacturing, Engineering, Continuous Improvement, and Quality teams regarding validation risks, challenges, and opportunities.
Provide technical support for investigations, deviations, CAPAs, and change controls related to cleaning validation.
Assist in developing and improving validation policies, programs, SOPs, and quality standards.
Support internal and external regulatory inspections as a subject matter expert in cleaning validation.
Review and approve controlled documents within area of expertise.
Support training and mentoring of Validation Engineers and Technicians as needed.
Maintain the effectiveness of Quality System elements relevant to the role.
Perform other duties as assigned.
Education
Bachelor’s degree in Engineering, Chemistry, Biology, or a related Science discipline preferred.
Experience
Minimum of 3 years of validation experience in a pharmaceutical manufacturing environment, with direct cleaning validation experience preferred.
Strong knowledge of cGMPs, pharmaceutical manufacturing operations, and validation principles.
Experience writing and executing validation protocols and final reports.
Familiarity with equipment change controls, risk-based validation approaches, and regulatory inspection support.
Knowledge, Skills, And Abilities
Strong understanding of cleaning validation principles in regulated manufacturing environments.
Excellent technical writing and documentation skills.
Strong analytical and problem-solving ability.
Ability to manage multiple projects and priorities with limited supervision.
Strong attention to detail and sound decision-making skills.
Effective verbal, written, and interpersonal communication skills.
Ability to work cross-functionally with a variety of teams and personalities.
Proficiency with standard business software, including word processing and spreadsheets.
Familiarity with safe work practices and GMP expectations.
Strong organizational skills and ability to perform well under pressure.
Mechanical aptitude and ability to interpret written instructions, diagrams, and schedules.
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.
Location:Crystal Lake IL
Hire Type: Direct
Shift : 1st
Compensation:$95,000-105,000
Benefits: eligible to receive a Full Employee Benefits Package that includes paid time off, paid holidays,.
Position Overview
The Cleaning Validation Engineer is responsible for the planning, execution, documentation, and lifecycle support of cleaning validation activities for manufacturing equipment, processes, and associated systems in a GMP-regulated pharmaceutical environment. This role ensures cleaning processes are scientifically sound, compliant with regulatory requirements, and capable of consistently meeting established acceptance criteria.
The engineer will develop and execute validation protocols, assess results, prepare final reports, and support change controls related to equipment, processes, and cleaning procedures. This position works closely with Manufacturing, Engineering, Quality Assurance, Quality Control, and Regulatory teams to ensure validated cleaning programs protect product quality and patient safety. The role also supports inspections, continuous improvement initiatives, and the development of validation procedures, SOPs, and quality standards.
Key Responsibilities
Serve as the validation representative on cross-functional project teams related to cleaning processes and equipment.
Lead and manage cleaning validation activities for new equipment, existing equipment changes, and process improvements.
Develop scientifically sound cleaning validation protocols with defined acceptance criteria, sampling plans, and assessment methods.
Coordinate and schedule execution of cleaning validation studies with Manufacturing, Quality, and Engineering teams.
Author, execute, and close cleaning validation studies and reports in support of equipment and process change controls.
Evaluate cleaning validation data to confirm repeatability, effectiveness, and compliance with internal procedures and regulatory expectations.
Prepare clear, thorough documentation packages summarizing study execution, results, deviations, conclusions, and recommendations.
Partner with Quality Control and Quality Assurance on sample strategies, residue limits, recovery studies, and acceptance criteria.
Maintain close communication with Manufacturing, Engineering, Continuous Improvement, and Quality teams regarding validation risks, challenges, and opportunities.
Provide technical support for investigations, deviations, CAPAs, and change controls related to cleaning validation.
Assist in developing and improving validation policies, programs, SOPs, and quality standards.
Support internal and external regulatory inspections as a subject matter expert in cleaning validation.
Review and approve controlled documents within area of expertise.
Support training and mentoring of Validation Engineers and Technicians as needed.
Maintain the effectiveness of Quality System elements relevant to the role.
Perform other duties as assigned.
Education
Bachelor’s degree in Engineering, Chemistry, Biology, or a related Science discipline preferred.
Experience
Minimum of 3 years of validation experience in a pharmaceutical manufacturing environment, with direct cleaning validation experience preferred.
Strong knowledge of cGMPs, pharmaceutical manufacturing operations, and validation principles.
Experience writing and executing validation protocols and final reports.
Familiarity with equipment change controls, risk-based validation approaches, and regulatory inspection support.
Knowledge, Skills, And Abilities
Strong understanding of cleaning validation principles in regulated manufacturing environments.
Excellent technical writing and documentation skills.
Strong analytical and problem-solving ability.
Ability to manage multiple projects and priorities with limited supervision.
Strong attention to detail and sound decision-making skills.
Effective verbal, written, and interpersonal communication skills.
Ability to work cross-functionally with a variety of teams and personalities.
Proficiency with standard business software, including word processing and spreadsheets.
Familiarity with safe work practices and GMP expectations.
Strong organizational skills and ability to perform well under pressure.
Mechanical aptitude and ability to interpret written instructions, diagrams, and schedules.
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.