Validation/Calibration Engineer

LHH; Lincolnshire (IL); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Vacation time (2 weeks)

Paid sick leave where applicable by州

Medical Insurance

Dental Insurance

Vision Insurance

401K

Life Insurance

Job summary

LHH Recruitment Solutions has partnered with a growing medical device/pharma manufacturer seeking a Validation/Calibration Engineer to join their team. This role focuses on IQ/OQ/PQ validation, calibration management, and quality system support in a highly regulated environment.

You will collaborate with manufacturing, QA, engineering, and regulatory teams to ensure FDA/ISO compliance, maintain documentation, and support audits and CAPA activities, while delivering strong technical writing and

Qualifications

• Bachelor's Degree in Engineering or related technical discipline.
• 2+ years in QA, Validation, or Quality Systems in medical device/pharma.
• Experience writing/executing IQ, OQ, and PQ protocols.
• Knowledge of FDA quality system regulations (21 CFR Part 820) and ISO standards.
• Experience with QMS and electronic quality documentation platforms.
• Familiarity with calibration management and equipment tracking.
• Strong technical writing and analytical skills.
• Ability to manage multiple projects in a fast-paced environment.
• Experience supporting FDA inspections and regulatory audits.
• Exposure to DMR, design controls, and risk management.

Responsibilities

• Develop, execute, and maintain IQ/OQ/PQ validation documentation.
• Coordinate qualification activities for equipment, processes, utilities, and systems.
• Analyze validation data and prepare compliance reports.
• Collaborate with manufacturing, quality, engineering, and regulatory teams.
• Support change control and assess quality impacts of modifications.
• Maintain and improve quality system processes for regulatory compliance.
• Assist investigations, CAPA, nonconformances, and continuous improvement.
• Support documentation related to design controls and device history records.
• Contribute to audits, inspections, and quality system initiatives.
• Coordinate calibration schedules and track calibration program assets.

Skills

IQ/OQ/PQ protocols

FDA regulations knowledge

QMS experience

Calibration management

Technical writing

Project prioritization

GMP/cGMP knowledge

Regulatory audits

Risk management

Education

Bachelor's Degree in Engineering

Tools

QMS software platforms

Device Master Records (DMR)

Job description

LHH Recruitment Solutions has partnered with a growing organization, and they are seeking a motivated Validation/Calibration Engineer -- Medical Device / Pharmaceutical Manufacturing to join their team. This is an outstanding opportunity for someone who enjoys bringing together validation, risk management, quality systems, and calibration activities in a highly regulated environment. This role offers broad exposure to quality engineering, equipment validation, regulatory compliance, and cross-functional collaboration while supporting products that positively impact patient outcomes.

The Validation/Calibration Engineer will support the development, execution, and maintenance of validation and quality system activities across manufacturing and engineering operations. This individual will help ensure compliance with FDA regulations, ISO standards, and internal quality requirements through validation protocol development, calibration coordination, risk management activities, and quality system support. The successful candidate will possess strong technical writing skills, experience within regulated manufacturing environments, and the ability to manage multiple projects while maintaining a high level of attention to detail.

Key Responsibilities:

Validation & Compliance:

• Develop, execute, and maintain validation documentation including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Support equipment, process, utility, and system qualification activities.
• Analyze validation data and prepare reports that demonstrate compliance with internal and regulatory requirements.
• Partner with manufacturing, quality, engineering, and regulatory teams to coordinate validation activities and project timelines.
• Support change control initiatives and assess quality impacts related to process or equipment modifications.

Quality Systems Support:

• Maintain and improve quality system processes to ensure regulatory compliance.
• Participate in risk management activities and support application of quality engineering principles throughout the product lifecycle.
• Assist with investigations, corrective actions, nonconformance activities, and continuous improvement initiatives.
• Support documentation related to design controls, device history records, and quality records as applicable.
• Contribute to audits, inspections, and quality system compliance initiatives.

Calibration Program Administration:

• Coordinate calibration schedules and associated activities.
• Track gauges, instruments, and equipment within the calibration program.
• Ensure instruments are calibrated within required timelines.
• Maintain calibration records and equipment location data within approved systems.
• Support compliance activities related to calibration and equipment management programs.

Qualifications and Skills:

• Bachelor's Degree in Engineering or a related technical discipline.
• 2+ years of experience in Quality Assurance, Validation, or Quality Systems within medical device or pharmaceutical manufacturing industry.
• Experience writing and executing IQ, OQ, and PQ protocols.
• Working knowledge of FDA and quality system regulations.
• Experience with quality management systems (QMS) and electronic quality documentation platforms.
• Familiarity with calibration management processes and equipment tracking systems.
• Strong technical writing, documentation, and analytical skills.
• Ability to prioritize multiple projects in a fast-paced environment.
• Knowledge of 21 CFR Part 820, 21 CFR Part 803, ISO 13485, ISO 14971, GMP, cGMP, GCP, and quality risk management methodologies.
• Experience supporting design controls, CAPA programs, complaints, document control, and product lifecycle quality activities.
• Experience supporting FDA inspections and regulatory audits.
• Experience working within a Quality Management System (QMS) environment and utilizing QMS software platforms.
• Exposure to Device Master Records (DMR), design controls, and risk management principles.

Compensation Range: $80,000 - $100,000

Benefits Offered: 2 weeks of vacation, paid sick leave where applicable by state law, Medical Insurance, Dental Insurance Vision Insurance, 401K, and Life Insurance.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers