Production Equipment Operator (5 Openings)
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Job Location:
Newton, MA - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
For further inquiries regarding the following opportunity please contact one of our Talent Specialists.
Hari at
Marshelin at
Hari at
Marshelin at
Title: Production Equipment Operator (5 Openings)
Duration: 12 Months
Location: Newton/Trivium/Hickory NC
Duration: 12 Months
Location: Newton/Trivium/Hickory NC
Relocation/Travel: Non-local candidates: Considered but must live within a commutable distance if hired.
Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.
Note: The first 4-6 weeks of assignment will be training on the floor in shifts 7 AM to 7 PM. 12-hour rotational shift (e.g. 3 days on/4 off 4 on/3 off) should be comfortable with this 12-hour rotation during the training phase. After training is complete assignment will be Monday - Friday: 8 AM - 5 PM. However occasional overtime and after-hours support can be expected to make required progress of the project.
Description:
Position Summary:
An Equipment Qualification Technician is responsible for ensuring that equipment used in manufacturing laboratory or other operational environments meets required standards of functionality reliability and compliance. They play a key role in validating and qualifying equipment to ensure it operates according to established specifications and regulatory requirements. Responsible for proving and demonstrating that newly installed or modified complex manufacturing equipment can run products according to customer specifications.
Key Responsibilities:
Equipment Qualification:
Perform Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) protocols for new and existing equipment.
Ensure equipment meets regulatory standards (e.g. FDA ISO GMP etc.) and internal quality requirements.
Document and report qualification results including deviations and corrective actions.
Hands on activities to troubleshoot and resolve technical issues with newly installed equipment.
Brainstorming with subject matter experts (SME) to do Root Cause Analysis (RCA).
Utilize standard process improvement methodologies such as FMEA Six Sigma DOE Hypothesis Tree DMAIC Fishbone Diagram.
Work with trained operators to learn how to setup equipment and be trainer to train others.
Testing and Calibration:
Conduct regular equipment testing and calibration to ensure proper functioning.
Troubleshoot and resolve issues with equipment performance.
Documentation and Reporting:
Prepare detailed reports documenting qualification processes outcomes and compliance.
Maintain accurate and up-to-date records of all equipment qualifications and calibrations.
Compliance and Regulatory Standards:
Ensure adherence to regulatory and industry standards such as Good Manufacturing Practices (GMP) Good Laboratory Practices (GLP) ISO standards or other applicable guidelines.
Assist in audits and inspections as needed.
Equipment Maintenance and Support:
Collaborate with engineering maintenance and quality teams to ensure proper equipment care and operation.
Provide training and technical support to staff using qualified equipment.
Continuous Improvement:
Identify opportunities to improve equipment qualification processes and implement best practices.
Stay updated on changes to regulatory standards and industry advancements.
Qualifications:
Education:
Associates or bachelors degree in engineering science or a related technical field. Relevant certifications may be considered.
Key Responsibilities:
Equipment Qualification:
Perform Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) protocols for new and existing equipment.
Ensure equipment meets regulatory standards (e.g. FDA ISO GMP etc.) and internal quality requirements.
Document and report qualification results including deviations and corrective actions.
Hands on activities to troubleshoot and resolve technical issues with newly installed equipment.
Brainstorming with subject matter experts (SME) to do Root Cause Analysis (RCA).
Utilize standard process improvement methodologies such as FMEA Six Sigma DOE Hypothesis Tree DMAIC Fishbone Diagram.
Work with trained operators to learn how to setup equipment and be trainer to train others.
Testing and Calibration:
Conduct regular equipment testing and calibration to ensure proper functioning.
Troubleshoot and resolve issues with equipment performance.
Documentation and Reporting:
Prepare detailed reports documenting qualification processes outcomes and compliance.
Maintain accurate and up-to-date records of all equipment qualifications and calibrations.
Compliance and Regulatory Standards:
Ensure adherence to regulatory and industry standards such as Good Manufacturing Practices (GMP) Good Laboratory Practices (GLP) ISO standards or other applicable guidelines.
Assist in audits and inspections as needed.
Equipment Maintenance and Support:
Collaborate with engineering maintenance and quality teams to ensure proper equipment care and operation.
Provide training and technical support to staff using qualified equipment.
Continuous Improvement:
Identify opportunities to improve equipment qualification processes and implement best practices.
Stay updated on changes to regulatory standards and industry advancements.
Qualifications:
Education:
Associates or bachelors degree in engineering science or a related technical field. Relevant certifications may be considered.
Preferred: 4-year Engineering degree or 2-year Technical degree.
Career Path: An engineering degree is highly valued for those aspiring to move into future permanent engineering roles.
Experience:
1 3 years of experience in equipment qualification or a related role.
1 3 years of experience in equipment qualification or a related role.
Minimum: 2 years of manufacturing experience preferred.
Direct experience running production equipment (not just forklifts). Maintenance/PM experience is also acceptable.
Open to High School Diploma if the candidate has significant solid manufacturing floor experience.
Technical Skills:
Knowledge of equipment qualification protocols (IQ OQ PQ).
Familiarity with regulatory requirements (e.g. ISO OSHA)
Proficiency with diagnostic tools and calibration equipment.
Industrial equipment operation and troubleshooting.
Mechanical Aptitude - Experience with threading complex machinery (pulleys wheels tubes) involving up to 24 different fibers.
Attention to Detail: Setup takes 1.5 hours; errors require starting the entire process over from Point A.
Troubleshooting: Ability to diagnose and repair equipment issues.
Soft Skills:
Strong analytical and problem-solving skills.
Excellent written and verbal communication.
Attention to detail and ability to follow procedures precisely.
Attention to Detail: Setup takes 1.5 hours; errors require starting the entire process over from Point A.
Troubleshooting: Ability to diagnose and repair equipment issues.
Soft Skills:
Strong analytical and problem-solving skills.
Excellent written and verbal communication.
Attention to detail and ability to follow procedures precisely.
Collaboration: Working side-by-side with existing operators tech-floor staff and engineers.
Accurately sharing data and performance results with the engineering team.
Once you become proficient you will be responsible for training less-experienced operators.
Other Requirements:
Ability to work independently and as part of a team.
Willingness to travel to different sites when necessary.
Physical ability to handle equipment and perform inspections.
Work Environment:
May involve working in laboratories manufacturing facilities or cleanroom environments.
Requires adherence to safety protocols and use of personal protective equipment (PPE) as needed.
This role is critical for ensuring equipment reliability and regulatory compliance supporting the success and integrity of operational processes.
Other Requirements:
Ability to work independently and as part of a team.
Willingness to travel to different sites when necessary.
Physical ability to handle equipment and perform inspections.
Work Environment:
May involve working in laboratories manufacturing facilities or cleanroom environments.
Requires adherence to safety protocols and use of personal protective equipment (PPE) as needed.
This role is critical for ensuring equipment reliability and regulatory compliance supporting the success and integrity of operational processes.
About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.
Key Skills
- Mechanic Experience
- Crane
- caterpillar
- Construction Experience
- Heavy Equipment Operation
- Water Truck Experience
- Commercial Driving
- Paving
- Dozer
- Equipment Repair
- Excavator
- Front Loader Truck
