The Harvest Consulting Group
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Jr. Validation Engineer

Location : Port Washington, WI
Job Type : Direct
Hours : Full Time
Travel : No
Relocation : No

Job Description :

Jr. Validation Engineer


 

Our client, an established, stable company is looking for a Jr. Validation Engineer to join their team in Port Washington, WI as a full-time employee. The Jr. Validation Engineer's primary purpose is to provide documented evidence through the development and execution of protocols, the equipment and processes used to manufacture regulated products, meeting all the FDA and company regulatory requirements. Our client offers stability and opportunities to elevate your skill set, competencies and level of responsibility along with an attractive benefits program.

 


Essential Functions: 


* Assist in administration activities such as scanning files, and retrieving and maintaining validation protocol files.




* Oversee and support the execution of validation protocols ( IQ, OQ, PQ ).
* Participate in the collection and analysis of validation data.
* Review documentation / protocols of the other Validation Team members.
* Support the ongoing validation of Quality Windows.
* Serve as the primary responsible party for the temperature / humidity monitoring units; This includes IQ, OQ, and PQ, validation of new units, daily monitoring, addressing alarms and outages, maintaining calibration, and contacting the vendor as needed.
* Validation of stability chambers.
* Write and execute cleaning verifications and validations.
* Prepare new validation protocols ( IQ, OQ, PQ ) and route for approvals.
* Track and maintain calibration records.
* Write and execute Excel spreadsheet validations.
* Sustain Validation Master Plan ( VMP ) and Cleaning Validation Master Plan ( CVMP ) schedules throughout the organization.


Required Qualifications :

Requirements:


* Recent graduate with an Associate's or Bachelor’s Degree with a strong emphasis in a Natural Science or related field, or experience with validation.


* Basic validation knowledge, including IQ, OQ and PQ, and a mechanical inclination.


* Familiarity with regulatory and GMP requirements for pharmaceutical manufacturing operations.


* PC proficiency to include Microsoft Office ( Word, Excel, Access, PowerPoint ) along with Google Suite, statistical analysis software, and contract management software.


* Ability to read, analyze, and interpret business information, journals, technical procedures, or governmental regulations.
* Excellent written and verbal communication skills to write reports and findings, and present to all levels of management in a clear and concise manner.
* Excellent organizational, self-starting, interpersonal, analytical problem solving, multi-tasking, prioritization and project management skills.


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