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Validation Engineer - Round Lake, United States - Automated Systems
Description
Job DescriptionJob Description
Validation Engineer
Contract:
6+ months duration with possible extensions
Location :
Round Lake, IL
ONSITE
Sponsorship is not available for this role now or in the future
Job Summary
Automated Systems, Inc.
is looking for a Validation Engineer to take on a 6+ month contract position with one of our global client's Pharmaceutical Manufacturing Facility located in Round Lake, IL.
The ideal candidate will handle the development and the execution of projects which include engineering studies, validation protocols and re-validations of manufacturing facilities, equipment, utilities, computerized systems, cleaning methods, and processes.
In this role, the Validation Engineer will lead specific C&Q activities for pharmaceutical manufacturing equipment and processes, ensure compliance with qualitystandards/requirements,
and industry standards (FDA, EMA, ISO, ICH, etc.).
In this contract role, the Validation Engineer will help drive all projects and duties will be completed in compliance with applicable cGMP, FDA, and all other regulatory agencies standards C&Q project completion and compliance while being able to thrive in a challenging and fast-moving environment in an efficient manner.
Duties and ResponsibilitiesAssists in the change management of facilities, utilities, systems, equipment (FUSE), and processes.
Assists in developing and managing the C&Q Programs/Processes including generating and maintaining site and project C&Q plans, overseeing C&Q
schedules/activities,
and coordinating various C&Q activities with cross functional teams.
Work with cross-functional teams in design reviews, impact assessments, generation of requirements, risk assessments, and other identified C&Q deliverables.
Serves as a project lead for projects of intermediate scope with cross-functional teams.
·
Schedule, plan, communicate, and manage documents and follow-up on validation activities. Interpret and apply regulatory requirements concerning validation activities.
Education, Experience and Skill Requirements
·
Bachelor's degree in Engineering or a Science-related field with 3 or more years of progressive experience in the pharmaceutical industry with
·
At least 2 years of acting in a
Qualification/Validation
role; or equivalent combination of education and experience.
·
Experience working with current validation principles, standard concepts, practices and procedures, and requirements in a cGMP regulated environment is necessary.
Demonstrated proficiency in five or more validation areas required.
·
Experience with Statistical Analysis preferred. Knowledge and understanding of cGMPs, industry guidance and aseptic techniques.
·
Tech savvy person- hands on person, not afraid to learn or use computerized systems and equipment.
·
Proficient in Word, Excel, and PowerPoint.
·
Understanding of statistical analysis tools and methods.
·
Good
interpersonal/communication/influencing/negotiation
skills.
·
Strong project management skills
Company Description We are a dynamic, project oriented consulting company offering individuals a wide variety of technical challenges. We are currently experiencing rapid growth, and are in need of talented individuals. ASI offers top wages and excellent benefits. ASI is an equal opportunity employer.
Company Description
We are a dynamic, project oriented consulting company offering individuals a wide variety of technical challenges. We are currently experiencing rapid growth, and are in need of talented individuals. ASI offers top wages and excellent benefits. ASI is an equal opportunity employer.
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