Quality Technician III – Equipment Qualification Technician
Newton, MA - USA
Job Summary
Employment Type: Contract
Duration: Approximately 12 Months (Potential Extension)
Schedule: Full-Time 40 Hours per Week
Location: Newton NC (100% Onsite)
Job Code: CRNGJP
Tekberry is seeking an experienced Quality Technician III Equipment Qualification Technician to support equipment qualification validation and compliance activities within an advanced manufacturing environment. This role is responsible for ensuring manufacturing and laboratory equipment meets operational quality and regulatory requirements.
As a Tekberry W2 employee you will have access to health benefits including medical dental vision and 401(k) options.
Position SummaryThe Equipment Qualification Technician III plays a critical role in validating and qualifying equipment to ensure reliable operation and compliance with internal quality standards and applicable regulatory requirements. This position supports new equipment installations troubleshooting calibration documentation continuous improvement and equipment lifecycle activities.
The ideal candidate will possess strong analytical and troubleshooting skills experience performing equipment qualifications and a passion for continuous improvement in manufacturing environments.
Key Responsibilities Equipment Qualification & Validation- Perform Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) activities for new and existing equipment.
- Ensure equipment meets internal quality requirements and applicable industry standards.
- Develop execute document and maintain qualification protocols and reports.
- Document qualification results deviations corrective actions and follow-up activities.
- Perform hands-on troubleshooting and technical support for newly installed and existing equipment.
- Conduct routine testing and calibration activities to ensure equipment performance and reliability.
- Diagnose and resolve equipment issues utilizing root cause analysis techniques.
- Collaborate with subject matter experts and cross-functional teams to identify and implement solutions.
- Prepare and maintain detailed qualification documentation calibration records and technical reports.
- Ensure documentation remains accurate current and audit-ready.
- Support internal and external audits and inspections.
- Maintain compliance with applicable standards including:
- ISO standards
- OSHA requirements
- Good Manufacturing Practices (GMP)
- Good Laboratory Practices (GLP)
- Identify opportunities to improve qualification processes and equipment reliability.
- Utilize structured problem-solving and process improvement methodologies including:
- FMEA
- Six Sigma
- Design of Experiments (DOE)
- DMAIC
- Root Cause Analysis (RCA)
- Fishbone Diagrams
- Hypothesis Trees
- Implement best practices to improve equipment performance and operational efficiency.
- Learn equipment setup and operation processes from experienced operators.
- Train and support personnel on qualified equipment and procedures.
- Collaborate closely with engineering maintenance manufacturing and quality teams to ensure proper equipment operation and care.
- Associates or Bachelors Degree in Engineering Science or a related technical discipline.
- Relevant technical certifications may be considered in lieu of formal education.
- 1-3 years of experience in equipment qualification validation manufacturing quality or a related technical role.
- Knowledge of equipment qualification methodologies including:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Experience troubleshooting industrial equipment and manufacturing systems.
- Familiarity with regulatory and quality requirements such as ISO and OSHA standards.
- Proficiency utilizing diagnostic and calibration equipment.
- Strong analytical and problem-solving abilities.
- Excellent written and verbal communication skills.
- Strong attention to detail and ability to follow procedures precisely.
- Ability to work independently and within cross-functional teams.
- Experience working in manufacturing laboratory cleanroom or regulated environments.
- Experience supporting equipment startup validation or commissioning activities.
- Knowledge of process improvement methodologies and statistical analysis tools.
- Experience supporting audits and regulatory inspections.
- Familiarity with GMP GLP or other regulated quality systems.
- Manufacturing facilities laboratories and cleanroom environments.
- Frequent interaction with engineering quality maintenance and operations personnel.
- Regular use of personal protective equipment (PPE) as required.
- May require occasional travel to support equipment qualification activities at additional sites.
We need hard-working reliable employees who are committed to delivering high-quality work in a safe and collaborative environment.
Tekberry Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability veteran status or any other protected characteristic protected by law.
Tekberry is a certified Minority Business Enterprise (MBE) and Disadvantaged Business Enterprise (DBE).
By applying for this position you consent to receive text messages from Tekberry regarding employment opportunities. Message and data rates may apply. Reply STOP to opt out at any time.
#INDHP