1+ months

Maintenance Planner/Calibration Scheduler

San, CA

Emergent BioSolutions is committed to assisting employees achieve their professional goals. Internal job postings are one of the tools available to employees at Emergent BioSolutions to assist in their career management. This enables current employees who have remained in their current position for a minimum of one year to apply for an open position.

JOB SUMMARY

The Coordinator for Maintenance, Calibration, and Validation will be responsible for supporting the programs and activities related to the lifecycle of validated instrumentation, equipment, and systems. This includes assisting with the planning, execution and documentation of all validation and calibration, and maintenance activities, to ensure that all instruments, equipment, and systems are maintained in a validated and calibrated state with a CFR 21 Part 11 Compliant system. This position includes collaboration with both contract service providers and Emergent personnel.


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

Participate in managing the life cycle of instrument, equipment and system validations performed at the San Diego site (including, but not limited to, Research and Development, Clinical Immunology, Process Development and Production, Product Development, Analytical Development, Quality Control and Facilities)
Maintenance and administration of the Asset Management tool(s) used for managing the sites validations, calibrations, and maintenance activities
Assist the Validation Manager in managing the annual budget and spend for the San Diego sites validation and calibration expenses
Assist the Validation Manager in developing, maintaining, and administering the San Diego sites Validation Policy, Validation Master Plan(s) and all SOPs related to the sites validation and calibration programs
Accountable for the scheduling and coordination of validation, calibration and maintenance activities required for equipment and systems
Assist the Validation Manager in projects associated with validation and calibration responsibilities
Oversee validation and calibration activities performed by contract service providers
Assist in providing responses to audit observations and manage audit related CAPA commitments
Schedules and coordinates service providers visits
Escorts service vendors when necessary
Maintains Equipment History Files
Compiles VCM departmental metrics monthly or when necessary
Maintains other miscellaneous departmental files
Represents VCM at meetings when directed
Maintain parts inventory in relation to the EFV function

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 from an accredited university or college, or the equivalent education and experience
3-5 years of relevant cGxP experience in a biopharmaceutical or life sciences development or manufacturing environment in calibration, validation, operations, engineering, or any combination thereof
Excellent technical writing and verbal communication skills
Ability to read/interpret engineering drawings and design documents
Ability to work as part of a high performing team and collaborate effectively with staff at all levels, and across all functions
Demonstrated ability to manage multiple activities while maintaining a high level of organization
Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision
Ability to make independent sound decisions and independently manage priorities in alignment with department and company goals
Experience in a CMMS System, preferably in SAP with transaction codes, but similar CMMS experience accepted

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: 2022-04-04 Expires: 2022-06-15

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Maintenance Planner/Calibration Scheduler

Emergent BioSolutions Inc.
San, CA

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