1+ months

Sr Validation Engineer

Rockville, MD 20850
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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.

I: Job Summary

The Sr. Val Engineer ensures cGMP regulatory compliance through adherence to site and corporate validation Plans, Policies, and Procedures. This position supports ensuring accountability and oversight within the validation program, validation projects, and leads innovation. Senior Validation Engineer will independently work on multi-faceted projects (Capital, Client and Overhead), manage multiple tasks/priorities of suitable complexity and with the Validation Manager provide resource allocations. Core competencies for this position are Courage, Collaborates, Communicates Effectively, Directs Work, Ensures Accountability and Customer Focus.

This position provides Subject Matter Expertise (SME) and oversight in multiple disciplines owned

by the validation department. These disciplines are; Commissioning and Qualification, Sterility

Assurance, Computer Systems Validation, Validation Maintenance/Risk Management, and Laboratory Systems Validation. The Senior Validation Engineer performs with a high degree of autonomy and represent the department on interdisciplinary teams. This position leads by example, achieves solutions to complex problems, serves as a technical expert, communicates effectively, collaborates and bridges GAPs. Senior Validation Engineers support engineering, quality, manufacturing sciences and technology, and manufacturing by providing SME support and accountability within the Validation department.

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.

II: Essential Functions

Technical Expertise

  • Create and execute commissioning, qualification protocols, and validation protocols and plans (CX/IQ/OQ/PQ), including identification and resolution of non-conformances consistent with site procedures and practices
  • Provide equipment, system and facility commissioning and qualification guidance and strategy execution during project planning and development phases
  • Reviews and approve technical documentation including system lifecycle design documentation (user requirements, functional and design specifications, commissioning and qualification protocols)
  • SME oversite of 2 disciplines within Validation: Commissioning and Qualification, Sterility

Assurance, Computer Systems Validation, Validation Maintenance/Risk Management, Serialization systems and Application of Statistical Technique

  • Perform equipment, aseptic processing, steam sterilization and process validation and their associated control systems
  • Review and approve department deliverables (protocols and quality systems) Perform investigations and implement corrective actions related to CAPAs and deviations.
  • Developing broader skills personally by applying this knowledge to work assignments and departmentally through resource and program development
  • Plan, Coordinate, and Execute assigned projects by effectively using Project Management

methodologies

  • Participate in regulatory inspection and response activities.
  • Represents validation on internal teams, committees and at technical conferences
  • Report status and progress of qualification activities or projects to the Leadership team.

Leadership Skills

  • Owns assigned Validation Plans, Procedures and Projects supporting program compliance
  • Manage and directs work for assigned projects ensuring activities are on time, within

budget, meet GxP and company requirements.

  • Possesses strong knowledge of current validation best practices, including governmental

regulations and GxPs

  • Demonstrated 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 Subject Matter Expert within the Validation department

Problem Solving

  • Proposes unique solutions to complex problems using technical proficiency, creativity and

collaboration with others through independent thought, communication and technical

writing

  • Supports and owns process troubleshooting, operations support, root cause analysis, and

risk assessment

  • Uses proven monitoring and problem-solving techniques such as SPC and DMAIC
  • Exercising judgment within broadly defined practices and policies in selecting methods,

techniques and evaluation criteria for obtaining results

  • Determine methods and procedures on complex assignments and implement them after

obtaining necessary stakeholder approvals

  • Determining methods and procedures on complex assignments and providing technical direction and guidance to 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.

III: 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
  • Demonstrated ability to use and operate independently within software common to Validation Departments: Microsoft (Word, Excel, Power Point), VISIO, Project, Kaye, Ellab

Skills

  • Possesses strong knowledge of engineering and related practices, including governmental regulations ISPE, EU, CFR 210, 211, Part 11, BPE.
  • Extensive C&Q Experience with systems such as Lyophilizers, Autoclaves, Aseptic filling line systems, Isolator systems, Automated and Manual Packaging systems, CIP, SIP, Serialization systems, Controlled Temperature units, Critical Utilities, Facilities, Equipment systems, Computer or Controls Systems preferably used in a GMP environment.
  • Read and interpret drawings such as PFDs, P&IDs and electrical schematics
  • 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.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities and business needs.

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

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

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

Industry

  • Biotechnology
Posted: 2022-01-07 Expires: 2022-12-05

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Sr Validation Engineer

Emergent BioSolutions Inc.
Rockville, MD 20850
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