Job Description
We are seeking a qualified professional to join our team as a Commissioning Qualification Validation Engineer. The ideal candidate will possess a strong background in commissioning, qualification, and validation of pharmaceutical facilities, utilities, and equipment. Experience in the pharmaceutical, medical device, or biotechnology industries is highly valued.
This role requires a high level of technical expertise, with a focus on developing documentation to support commissioning, qualification, and validation activities. The successful candidate will be responsible for writing and executing protocols, conducting field verifications, and preparing summary reports at client sites.
Required Skills and Qualifications
* Bachelor's or Master's degree in a relevant science or engineering field, or equivalent years of hands-on experience
* 2-7 years' experience performing commissioning and/or qualification activities in an FDA-regulated industry
* Expertise in life science manufacturing processes, including biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy, or equivalent experience
* Familiarity with Baseline Guide 5 (Second Edition) a plus
Benefits
* Highly competitive salary range: $73,150 - $115,000 per year
* Continuing education opportunities (internal and external)
* Challenging projects in a rapidly evolving field
Others
The ideal candidate will have excellent technical problem-solving skills, with solid knowledge of typical project technical issues. They will also possess high attention to detail, ability to multitask, and take initiative to accomplish assigned tasks accurately by established deadlines. Additionally, they should be able to work independently, while quickly building and nurturing a project team.
Key Responsibilities
* Develop documentation to support commissioning, qualification, and validation activities
* Write and execute protocols
* Conduct field verifications
* Prepare summary reports at client sites
This is an exciting opportunity for a motivated and experienced professional to join our team and contribute to the success of our clients. If you meet the requirements and are passionate about commissioning, qualification, and validation, please submit your application.