CSV Specialist (Remote Position) at Mentor Technical Group | Torre

CSV Specialist (Remote Position)

You'll ensure pharmaceutical safety and efficacy by leading critical C&Q and validation initiatives.
Emma highlights
This highlight was written by Emma’s AI. Ask Emma to edit it.
Full-time

Legal agreement: To be defined

USD75.4K - 100K/year

~COP150M - 200M/year

+ Equity

+ Bonuses

location_on
Remote (for United States residents)
Match
skeleton-gauges
You have opted out of job matches in .
To undo this, go to the 'Skills and Interests' section of your preferences.
Review preferences
Shared by
Emma of Torre.ai
about 1 month ago

Requirements and responsibilities


Mentor Technical Group (MTG) provides specialized technical support and solutions for FDA-regulated industries. MTG is recognized for its expertise in life sciences engineering, ensuring compliance with pharmaceutical, biotechnology, and medical device safety and efficacy standards. Resources considered for this RFP will support pharmaceutical manufacturing operations and must meet the following minimum qualifications.Responsibilities:Support Commissioning and Qualification (C&Q) activities for plants and equipment.Develop, review, and maintain commissioning and qualification procedures and documentation.Write, review, and approve C&Q protocols and reports for various systems, including HVAC, utilities, production equipment, and lab equipment.Execute commissioning and qualification activities and coordinate with internal teams and external consultants to ensure timely delivery.Manage change controls and deviations related to plants and equipment.Support maintenance and calibration functions to improve compliance and quality.Provide expertise in troubleshooting and root cause investigations.Facilitate the transfer of technical knowledge across units and sites.Qualifications / Requirements / Knowledge / Skills:Proven background in pharmaceutical product manufacturing, specifically in sterile packaging operations.Demonstrated experience in Commissioning and Qualification (C&Q) activities.Strong knowledge of current Good Manufacturing Practices (cGMP) and other regulatory requirements.More than 5 years of experience in Equipment and Computer System Validation within pharmaceutical facilities.Experience with digital validation solutions (e.g., ALM or equivalent).Excellent skills in writing validation, commissioning, and technical documentation in English.Proficient in MS Office applications (Word, Excel, PowerPoint, etc.).Bilingual: fluent in English and Spanish.
Optionally, you can add more information later (benefits, pre-screening questions, etc.)
check_circle

Payment confirmed

A member of the Torre team will contact you shortly

In the meantime, continue adding information to your job opening.