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Validation Specialist (Chemistry Lab)
RCM Technologies, Inc. | Life Sciences / Data & Solutions
🇵🇷 Puerto Rico
On-site
1 month ago
- calibration
- Technical Writing
- GMP
1 month ago
Title or Role:Validation Specialist (Chemistry Lab.)
Location:Jayuya, Puerto Rico, 100% on-site
Length of Contract:Minimum six months (contracts renewed every six months as needed)
Position Description:
The Validation Specialist will develop, execute and prepare final reporting of the chemistry laboratory equipment validation/qualification protocols.
Responsibilities:
- Develops and executes validation protocols and reporting.
- Develops, organizes, analyzes, and presents interpretation of results for the equipment qualification projects of significant scope and complexity.
- Employs advanced validation techniques and/or modifications of advanced techniques within area of validation expertise.
- Applies knowledge of validation principles and practices outside of area of expertise to broad variety of assignments in related fields.
- Develops technical solutions to complex problems requiring the regular use of ingenuity and creativity.
- Works with manufacturing, process development, utilities, facilities, labs in developing requirements and recommendations for large and/or highly complex processes, system/facility modifications.
- Works with project managers to complete the validation responsibilities of projects within schedule, budget, and quality constraints.
- Ensure compliance with all company procedures and all applicable regulatory agency requirements.
- Experience in IQ/OQ/PQ protocols developing, execution and reporting.
- Experience in reviewing equipment calibration and preventive maintenance specifications.
- Experience in performing statistical analysis: Normality, tolerance limits, capability and gage R&R tests.
- Knowledge of computer system validation life cycle (validation plan, traceability matrix, URS, risk assessments).
- Good Technical writing skills.
- Must be fully Bilingual (English/Spanish) and must have good communication skills both oral and written.
- Experience working in a regulated environment.
- Demonstrated interpersonal skills, including the ability to listen, resolve problems, deal with unresolved issues, delays and unexpected events, and the ability to effectively communicate and maintain rapport with supported customers.
Education & Certifications:
- Bachelor's degree in science or engineering.
- Minimum 5 years' experience within the GMP regulated industry performing similar tasks.
Equal Opportunity Employer:
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.
About RCM:
RCM is publicly traded on Nasdaq under the symbol RCMT. RCM is a business and technology solutions provider with world-class talent in key market segments. We help design, build, and enable the Industries of Tomorrow, Today. Operating at the intersection of resources, critical infrastructure, and modernization of industries, RCM is a provider of services in Life Sciences, Data & Solutions (IT), Healthcare, Engineering, Aerospace & Defense, and Process & Industrial.
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.
Validation Specialist (Chemistry Lab) · RCM Technologies, Inc. | Life Sciences / Data & Solutions