1+ months

Sr. Validation Engineer

Baltimore, MD 21202


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 Senior Validation Engineer manages and prioritizes all phases of assigned validation projects from concept through performance qualification and ongoing support of CGMP operations. They ensure CGMP regulatory compliance through adherence to site and corporate validation Plans, Policies and Procedures. The position provides Suject Matter Expertise (SME) and oversight in multiple disciplines owned by the Validation Department. These disciplines include but are not limited to: Commisisiong and Qualification, Sterilitization and Cleaning Validation, as well as Validation Maintenance/Risk Management. The Senior Validation Engineer performs with a high degree of autonomy and represents the department on interdisciplinary teams. This position leads by example, achieves solutions to complex problems, serves as a technical expert, communicates effectively and collaborates. Along side the Sr. Manager, Validation, this position is a primary interface for customers, clients and regulators.

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


Leadership:
Assist in developing project equipment qualification strategies and schedules using risk based approach to ensure both compliance to desired validation state and speed.
Develop/improve systems that promote and result in improved efficiency within the department/company.
Possesses strong knowledge of current validation practices, including governmental regulations and GxPs.
Demonstrates success in technical proficiency, creativity and collaboration with others through independent thought, communication and technical writing.
Provide customer focus supporting engineering, quality, manufacturing sciences and technology and manufacturing as a SME and leader within the Validation department.

Technical:
Review and approve department deliverables ensuring adherence to the site and corporate Plans, Policies and Procedures. This includes but is not limited to potocols, reports, SOP, Plans, etc.
Review and approved supporting documentation of the Operations quality management systems, which require validation awareness, or oversite, and ensuring compliance of validation.
Author and execute alidation documents (protocols and reports) for utilities, process equipment, laboratory instruments, controlled temperature units and steam sterilization validation activities.
Work within a cross-functional team including engineering, operations and qualifity to ensure completion of qualification activities on time.
Temperature mapping using the Kaye Validator 2000 or AVS system
Perform periodic reviews of qualified systems.
Performs other duties as assigned

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 managements assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

Bachelors Degree in Science or Engineering discipline. Other disciplines and/or equivalent job experience will be considered.
Minimum of 8 years of experience in the area of validation.
Strong understanding of Regulatory Guidance Framework, FDA/EU, Industry Best Practices and GxPs.
Subject Matter Expertise in two (2) of the following Validation disciplines: Commissioning and Qualification (including manufacturing equipment, utilities, laboratory equipment, etc.), Sterility Assurance, Cleaning Validation and Validation Maintenance/Risk Management.
Basic skills and fluency in Microsoft Word, Outlook and Excel
Strong technical writing skills
Strong oral and written communication skills

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: 2022-04-08 Expires: 2022-06-12

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Sr. Validation Engineer

Emergent BioSolutions Inc.
Baltimore, MD 21202

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