Equipment Qualification and Process Validation Consultant - RCM Technologies, Inc. | Life Sciences & IT
Dorado, PR 00646-3315
About the Job
Full Time Contract
Title: Equipment Qualification and Process Validation Consultant
Location: Dorado, Puerto Rico
Length of Contract: 3 months+
Company Description:
Our client is a major manufacturing as well as research and development hub for the company. It is one of the largest medical device manufacturing facilities in the world, producing a wide range of products used in various medical specialties.
Position Description:
The Validation Specialist will play a crucial role in ensuring the quality and reliability of manufacturing equipment and processes. This individual will be responsible for conducting comprehensive validation activities, including equipment qualification, process validation, and troubleshooting.
Responsibilities:
RCM is a leading provider of Business, IT, and Engineering Services to over 1,000 clients in the commercial marketplace. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.
Equal Opportunity Statement:
RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Pay Transparency:
RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices.
Disclaimer:
This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job, duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Title: Equipment Qualification and Process Validation Consultant
Location: Dorado, Puerto Rico
Length of Contract: 3 months+
Company Description:
Our client is a major manufacturing as well as research and development hub for the company. It is one of the largest medical device manufacturing facilities in the world, producing a wide range of products used in various medical specialties.
Position Description:
The Validation Specialist will play a crucial role in ensuring the quality and reliability of manufacturing equipment and processes. This individual will be responsible for conducting comprehensive validation activities, including equipment qualification, process validation, and troubleshooting.
Responsibilities:
- Conduct Equipment Qualification:
- Develop and execute comprehensive equipment qualification protocols.
- Validate equipment performance, accuracy, and precision.
- Investigate and document any deviations from established specifications.
- Ensure compliance with regulatory requirements (e.g., FDA, ISO).
- Perform Process Validation:
- Develop and execute process validation protocols.
- Assess process capability and control.
- Identify and address process risks and uncertainties.
- Ensure process consistency and reproducibility.
- Troubleshoot Equipment Issues:
- Diagnose and troubleshoot equipment malfunctions.
- Identify root causes of equipment failures.
- Implement corrective actions to prevent recurrence.
- Maintain Validation Documentation:
- Create and maintain detailed validation documentation.
- Ensure compliance with documentation standards and regulatory requirements.
- Organize and archive validation records.
- Collaborate with Cross-Functional Teams:
- Work closely with engineering, manufacturing, quality control, and regulatory affairs teams.
- Communicate effectively to share findings and recommendations.
- Preferred experience in molding and laser equipment validation.
- Strong understanding of validation principles and methodologies.
- Experience in equipment troubleshooting and problem-solving.
- Knowledge of regulatory requirements (e.g., FDA, ISO).
- Excellent analytical and problem-solving skills.
- Strong documentation and communication skills.
- Bachelor's degree in engineering (e.g., Mechanical, Electrical, Chemical).
- 2-5 years of experience in equipment and process validation in Medical Device Industry.
RCM is a leading provider of Business, IT, and Engineering Services to over 1,000 clients in the commercial marketplace. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.
Equal Opportunity Statement:
RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Pay Transparency:
RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices.
Disclaimer:
This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job, duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Source : RCM Technologies, Inc. | Life Sciences & IT