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Validation Engineer

Location: 

Canton, MA, US, 02021 Canton, MA, US, 02021

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

 

VALIDATION ENGINEER

 

Emergent BioSolutions is currently seeking a Validation Engineer for our Canton site location. The successful candidate will have a BS in Engineering, Biology or in another related field, 1-3 years of related industry experience and have strong communication skills. The ideal candidate will have basic entry level knowledge of validation principles and concepts and possess general knowledge of engineering and related practices including governmental regulation  - ISPE, EU, CFR 210, 211, Part 11 BPE. In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.

 

THE COMPANY

 

Emergent BioSolutions is dedicated to one simple mission—to protect and enhance life.

As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats.

 

We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.

 

THE OPPORTUNITY

 

The Validation Engineer authors, reviews, executes validation documents and activities with cross-functional teams including performing commissioning and qualification activities, temperature mapping, sterilization validation and creating traceability matrixes.  The position requires entry level experience in validation using the Kaye Validator equipment, and basic knowledge of validation concepts and industry standards.

The Validation Engineer will also be responsible for providing tactical support to ongoing validation activities at the Canton site.

 

ESSENTIAL FUNCTIONS

 

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

  • Possesses basic entry level knowledge of commissioning, qualification validation and related practices, including applicable regulations. 
  • Demonstrated success in collaborating with others and independent thought and problem skills
  • Develops, execute and review commissioning, qualification and validation protocols consistent with site procedures and practices
  • Perform temperature mapping, equipment, steam sterilization, and cleaning validation,
  • Executes validation activities according timeline commitments, site and team metrics
  • Represents the team as an individual contributor on projects and in the resolution of complex technical issues.
  • Provide inputs and data for CAPAs and Deviations.
  • Exercising judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining adequate and compliant results
  • Team player that collaborates with key stakeholders

 

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

  
MINIMUM EDUCATION, EXPERIENCE & SKILLS: 

 

  • BS in Engineering, Biology or related field
  • 1-3 years related industry experience
  • Basic entry level knowledge of validation principles and concepts
  • Basic skills and fluency in Microsoft Word and Excel
  • Possesses general knowledge of engineering and related practices, including governmental regulations – ISPE, EU, CFR 210, 211, Part 11, BPE. 
  • Entry level experience with systems such as CIP, SIP, Autoclaves, Controlled Temperature units, Critical Utilities, Facilities, Equipment systems, preferably used in a GMP environment
  • Strong communication skills
  • Must be a team player
  • Makes decisions exercising judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.  Ensure alignment and communication of issues and strategies. 

 

PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

 

The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.

The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, sense of smell, lift/carry 10 lbs.  Use phone, fax, copier, and computer.  Use hand tools. Organize/coordinate, analyze/interpret, problem solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents.  Drive automatic/standard vehicle. Work around noise above conversation level, in hot/cold temperatures, in high humidity, where ventilation is needed, in multiple locations, with restricted access to laboratory.

 

Requires vaccination against different viruses including Vaccinia virus and Japanese Encephalitis virus.

 

Interested? Please visit www.emergentbiosolutions.com to apply today!

 

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: Boston