1+ months

Computer Systems Validation Engineer

San, CA
  • Jobs Rated
    22nd


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
Computer System Validation Engineer ensures cGMP regulatory compliance through adherence to site and corporate Validation Plans, Policies, and Procedures with a specialized focus in CSV. This position supports the initial commissioning, qualification and the revalidation program including periodic review for computerized systems and equipment validation. Core competencies for this position are Collaborates, Communicates Effectively, Plans and Aligns and Customer Focus.

This position is the Subject Matter Expertise (SME) for Computer Systems Commissioning and Qualification, as well as Validation Maintenance, and Risk Management with a strong focus on computerized systems associated and integrated with laboratory and manufacturing instruments and equipment. The CSV Engineer creates, executes, and summarizing Commissioning, Qualification, and Validation Maintenance activities with an appropriate amount of oversight from peers and Management. This position demonstrates a high degree of appreciation and understanding of GxP practices ensuring validation protocols developed are compliant with company requirements.

The CSV Engineer manages tasks for assigned work using courage, technical problem solving, soft skills, communication, and technical writing. This position manages assigned tasks, effectively communicates, and provides required updates to management.

This position supports the needs of a 24-hour production facility. It is a 1st shift position but can support off shift and weekend efforts as they occasionally arise.

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

Technical Expertise

Create, execute, and summarize validation protocols and reports
Collaborate and assist staff, contractors, and vendors with creation and execution of validation protocols and reports
Computerized Validation Expert
Analyze data to verify acceptance criteria were met
Perform periodic reviews of equipment /systems as part of Validation Maintenance
Demonstrated ability to grasp technical concepts and develop SME level understanding
Develop Proficiency with Data-Logger Equipment and Technology
Manage assigned tasks ensuring activities are on time, meet GxP and company requirements
Effectively communicate and provide required updates to management
Plan, Coordinate, and Execute assigned tasks

Problem Solving

Support investigation/resolution of non-conformances and/or deviations associated with validation studies
Critically review data to ensure completeness, accuracy, and compliance
Supports and owns process troubleshooting, operations support, root cause analysis, and risk assessment (Deviation, CAPA, Change Control)

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

Education: BS preferably in Science or Engineering discipline. Other disciplines and/or a minimum of 5-7 years pharmaceutical cGMP experience will be considered
Skills: Strong problem-solving and critical thinking skills with ability to conduct technical operations and achieve operational goals
Skills: Strong organization skills to handle multiple tasks at differing levels of complexity
Skills: Proficient technical written and verbal communication skills
Abilities: Demonstrated ability to use and operate independently within common software such as Microsoft (Word, Excel, Power Point), VISIO, Project
Abilities: Exercise judgment for following defined practices and policies

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

Jobs Rated Reports for Computer Systems Analyst

Posted: 2022-04-04 Expires: 2022-06-03

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Computer Systems Validation Engineer

Emergent BioSolutions Inc.
San, CA

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