1+ months

Sr. Validation Engineer

Canton, MA 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.

Job Summary
The Sr. Validation Engineer authors, reviews and executes qualification and validation documents with processes and coordinates activities with cross-functional teams including performing FATs, validation assessments, quality deviations and change controls. The position requires experience with GDP, authoring documents, use of the Kaye Validator 2000 or similar equipment, and knowledge of the corporations products and processes.

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 governmental regulations. Developing broader skills and applies this knowledge and skills to perform a variety of standard activities.
Demonstrated success in technical proficiency, creativity, and collaboration with others and independent thought
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 design documentation (user requirements, functional and design specifications, commissioning and qualification protocols)
Perform equipment, aseptic processing, steam sterilization, cleaning validation and process validation and their associated control systems
Manages validation activities within timeline commitments including developing a plan with timeline, deliverables, and accountabilities
Represents the validation team on projects and in addressing issues. Develop and recommend solutions outside general practices with a focus on continuous improvement and compliance.
Develop systems that promote and result in improved efficiency within the department and company.
Summarize major validation activities in summary reports following Emergent applicable procedures.
Represents validation on internal teams, committees and at technical conferences

Problem Solving
Provide review and input for CAPAs and Deviations.
Solves a range of varied and complex problems requiring analysis/interpretation and are solved using knowledge/skills, precedents and practices. These include but not limited to process troubleshooting, operations support, root cause analysis, and risk assessment to document and accept risk.
Exercising judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
Determine methods and procedures on new moderately complex assignments and implement them after obtaining necessary stakeholder approvals.
Determining methods and procedures on new complex assignments, and providing technical direction to other engineers within the validation department
Demonstrate strong leadership and management qualities when working within the department and other stakeholder groups that yield results.

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.

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

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

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable 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.

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 actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe 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.

Categories

Industry

  • Biotechnology
Posted: 2022-01-05 Expires: 2022-09-09

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Sr. Validation Engineer

Emergent BioSolutions Inc.
Canton, MA 02021

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