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Sr Validation Engineer at EBSI

Posted in Architecture 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Canton, Massachusetts





Job Description:

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.

The Sr. Validation Engineer authors, reviews, executes validation documents and leads activities with cross-functional teams including performing commissioning and qualification activities, system impact assessments, validation impact assessments, reviewing system specification documents and creating traceability matrixes.  The position requires senior level experience in validation use of the Kaye Validator equipment, and solid knowledge of validation concepts and industry standards.

The Sr. Validation Engineer will also be responsible for providing leadership and technical guidance to the team aimed at implementing best practices and improving the overall performance of the team.
Responsibilities
Technical Expertise
• Possesses strong knowledge of commissioning, qualification validation and related practices, including applicable regulations. 
• Demonstrated success in technical proficiency, creativity, and collaboration with others and independent thought and complex problem skills
• Develops, execute and review commissioning, qualification and validation test plans & protocols consistent with site procedures and practices
• Reviews and approve commissioning, qualification and validation related system lifecycle documentation (user requirements, functional and design specifications, commissioning and qualification protocols)
• Perform computer, equipment, aseptic processing, steam sterilization, cleaning validation, analytical instrument and process validation
• Manages validation activities according timeline commitments, site and team metrics including developing an execution plan with timeline, deliverables, and accountabilities
• Represents the team as a leader on projects and in the resolution of complex technical issues. Develop and recommend solutions outside general practices with a focus on continuous improvement and compliance.
• Develop systems and processes that promote and result in improved efficiency within the department and company.

Problem Solving
• Provide validation review and input for CAPAs and Deviations.
• Solves a range of varied and complex technical problems requiring analysis and interpretation using knowledge, experience, skills, and industry practices. 
• Exercising judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining adequate and compliant results
• Demonstrate strong complex problem-solving skills when working with issues that may have a negative impact on compliance and the business
• Team player that develop solutions to complex issues

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.
 Education, Experience & Skills
Requirements
• BS Engineering/Chemistry/Microbiology or related field and/or a Minimum 8 years related industrial experience in system qualification or validation
• Expert knowledge of validation principles and concepts
• Basic skills and fluency in Microsoft Word and Excel

Skills
• Possesses strong knowledge of engineering and related practices, including governmental regulations – ISPE, EU, CFR 210, 211, Part 11, BPE. 
• Reputation as emerging leader in field with sustained performance and accomplishment
• Experience with systems such as CIP, SIP, Autoclaves, Controlled Temperature units, Critical Utilities, Facilities, Equipment systems, Computer or Controls Systems preferably used in a GMP environment
• Strong communication and computer skills
• Demonstrates success in technical proficiency, creativity, and collaboration with others and independent thought. 
• 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 Requirements
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, lift/carry 25lbs, pull 50lbs  Use phone, fax, copier, computer, copier, hand tools.  Noise above conversation level, hot/cold temperatures, high humidity, and restricted access laboratory, exposure to animals, animal areas, or equipment used in animal area environment.  Organize/coordinate, analyze/interpret, calibrate precise measurements, problem-solve, make decisions, supervise, plan, communicate, prepare written communications, prepare transaction documents.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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 .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.