Validation Engineer in Atlanta GA

Full-time @Steris in Biotech jobs , in Developer jobs , in Engineer jobs , in Medical jobs , in Technology , in Thermal Engineering jobs
  • Atlanta, GA, US, 30301 View on Map
  • Apply Before : August 18, 2022

Job Description

Join Steris as Validation Engineer in Atlanta Georgia. At the Steris you will perform tasks as listed below, Apply Steris career in Atlanta GA.

 

Position : Validation Engineer

Job Category: Engineering

Work location : Atlanta, Georgia

Job Segment : Developer, Biotech, Medical, Thermal Engineering, Engineer, Technology, Science, Healthcare, Engineering

 

Description: 

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
The Role
A Validation Engineer is responsible for the development and delivery of validation-related services in cGMP regulated markets including pharmaceutical, biotechnology, medical device and laboratory research.   The position’s primary responsibility is the authoring and execution of validation protocols on STERIS equipment but is also expected to function as a subject matter expert on all aspects of the validation process, providing consultative support and training to both STERIS Service Representatives and Customers as well.

This role is home based and may require 50% travel to customer sites.
What You Will Do

Develop, author, and execute Validation/Qualification protocols including Cycle Development, IQOQ, and PQ on STERIS Life Science equipment according to STERIS Service and Customer requirements.  During the execution process, identify and resolve any non-conformities, analyze results, and incorporate into a final summary report using Good Documentation Practices (GDP).
Work with Customers to define Scope of Work for the development of a formal PQ quote and protocol using Customer defined load configuration on Life Science equipment.
Develop validation project schedules and support all other project deliverables to meet deadlines and LS Specialty Engineering department standards.
Work with Specialty Services Engineering to develop validation standards, procedures, guidelines and best practices which includes exploring new techniques, methods, and other industry practices on Life Science equipment. 

What You Will Do – cont’d

Maintain current knowledge of regulatory and industry standards for validating LS equipment.
Train Field Service Engineers on executing standard PQ protocols and oversees their work.
Additional departmental responsibilities may be assigned as per business needs.
 Up to 50% travel to the customer site may be required. (International and Domestic)
Maintain Test Equipment and refurbish as needed.
Lift up to 50 lbs. and pull about 100 lbs. pelican cases with casters.

Education Degree
Bachelor’s DegreeWhat You Need To Be Successful

A curious quick learner and problem solver.
A “continuous-improvement” mindset to increase process efficiencies.
A team player and, also an individual contributor.
“Go get it” mindset.
An effective communicator in all forms of communications.
Ability to read P&ID and engineering drawings.
A tech savvies to be able apply in protocol development.
Good working knowledge of MS Suite.

#LI-PC1

#ZR-PC
What You Need To Be Successful – Cont’d

Ability to represent STERIS values with customers.
Must have 3-5 years of demonstrated experience in Qualification/Validation of process equipment including Steam Sterilizers, Pure Steam Generators, Pure Water Stills and cGMP Washing equipment using cGMP, ISPE, GAMP, ASTM, EN285, HTM2010, applicable ISO Standards and ICH guidelines.
Work experience in both electronic/electromechanical and computer-controlled equipment.
Demonstrated cGMP (GDP) documentation proficiency.
Extensive Kaye Validator experience in thermal mapping of chambers and heat penetration studies of loads.
Understanding of appropriate handling and interpretation techniques for Biological Indicators.

What Will Help You

A proactive self-starter with motivation to provide strong deliverable quality and a positive Customer experience.
Excellent oral, written and interpersonal skills in a high-pressure environment.
Demonstrated strong organizational, analytical and problem-solving skills with ability to make critical decisions on a routine basis. High level of attention to detail and driven towards results.
Ability to effectively prioritize and manage multiple project tasks to meet targeted deadlines.
Must have an appropriate background for generating, interpreting and compilation of raw measurement data into validated PQ records and final reports.
Must have experience and solid understanding of pharmaceutical cGMPs, FDA regulations and other regulatory requirements.
Computer skills: proficient in Microsoft Office.

Must have valid driver license and ability to obtain a passport.

What We Offer
The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid-time off, holidays, matching 401(k), annual merit, and incentive plans.  Join us and help write our next chapter.
 

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.

Nearest Major Market: Atlanta

Job Tags : Steris careers in Atlanta, Engineering jobs in Atlanta GA, Developer jobs hiring, Biotech jobs in Atlanta, Medical careers, Atlanta jobs in Developer sector, Jobs nearby in Atlanta Georgia, Steris hiring nearby me in Atlanta GA, Thermal Engineering jobs,

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