1+ months

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 Validation Engineer authors, reviews, and executes qualification and validation documents with processes including process equipment, controlled temperature units, critical utilities, facility, and sterilization of equipment. The position requires experience with GDP, authoring and reviewing documents, and use of Industry and Regulatory Guidelines.

ESSENTIAL FUNCTIONS
Author, review, and execute qualification and validation documents and manage validation activities of cross-functional teams including engineering, operations, and quality
Temperature mapping using Temperature Mapping Systems
Perform qualification work on critical utilities systems, new equipment, processes and control systems
Perform qualification work on sterilization equipment
Perform Cleaning Verification and Validation
Perform qualification work on controlled temperature-controlled units
Write final reports summarizing qualification work
Perform validation assessments on corrective work orders
systems
Participates in the change control process and provides assessments from a advising on validation perspective issues, as appropriate
Hands on role in the development and execution of DQ, IQ, OQ and PQ activities
Provide technical assistance on current US FDA and EU validation requirements for solid Bulk Drug Substance manufacturing, aseptic processing, cleaning, and sterilization of equipment.
Participate in requalification of equipment, facility and utilities. Ensure that the validation status of equipment and systems are within cGMP compliance within cGMP at all times.
Maintain validation documentation through the approval and implementation of changes to relevant systems and assist in generating validation/ revalidation plans.

MINIMUM EDUCATION, EXPERIENCE, SKILLS
Minimum Requirements
Bachelors Degree in Engineering or closely related scientific field
2-5 years of experience with the following:
o GxP procedures and guidelines
o Good Documentation Practices
o Authoring, reviewing, and approving qualification protocols
o Must have experience with temperature mapping equipment
o Steam in Place (SIP)
o Clean in Place (CIP)
o Requalification
Preferred Experience
Preferable: Post-graduate studies as appropriate to augment primary degree
Experience with Quality management (CAPAs, Deviations, Change Control, Quality Risk Management)
Computerized System Validation
Data Integrity Compliance
Skills
Must have strong technical writing skills
Must have strong oral and written communication skills
Must have strong computer skills including experience with the following:
o MS Excel
o MS Word
o MS PowerPoint

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: 2022-07-20

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Validation Engineer

Emergent BioSolutions Inc.
Canton, MA 02021

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