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CSV / CQV Engineer
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$111k-138k (estimate)
Full Time 6 Days Ago
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Randstad Life Sciences US is Hiring a CSV / CQV Engineer Near Indianapolis, IN

The company's purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. We also aim to reward those who invest their money, time and ideas in our company.

Job Purpose

  • Write, summarize, and drive project change controls for cleanroom, clean utilities, EMS and associated systems.
  • Laydown clear plan for drafting, reviewing, and pre-approving commissioning and qualification documents for cleanroom, clean utilities, EMS, and other associated systems.
  • Execute commissioning and qualification activities and resolve deviations (if any) in a timely manner.
  • Work with project team to ensure all activities are carried out in accordance with the project timeline.
  • Ensure all documents are written in accordance with Quality Manual and procedures.
  • Ensure all utilities related drawings are available and updated in the commissioning and qualification documents.
  • Develop required procedures and handover to system owner in a timely manner.
  • Coordinate with various internal and external stakeholders to refine the list of activities scheduled and maintain the best possible granularity in the schedule.
  • Ensure project activities are sequenced in the most logical manner ensuring completion of pre-requisites timely and orderly.
  • Escalation of potential issues that may arise from time to time during the execution of project activities and collaborate with the cross-functional teams towards resolution.

Major Accountabilities

  • Drafting, reviewing and pre-approval of protocols in a timely manner
  • Adherence to overall project schedule
  • Ensure all commissioning and qualification protocols are compliant to quality manual and site procedures.
  • Fosters an environment that enables the most efficient and effective work processes to achieve project objectives and milestones.
  • Implementation of and compliance with all the guidelines and requirements for safe work, environment protection and property protection.

Key Performance Indicators – KPIs

  • Timely and complete commissioning and qualification packages for the systems.
  • Adherence to project schedule of activities
  • Compliance with Quality Manual and RLT Site SOPs.

Education

Minimum: Degree in Science and Certification in Project Management (preferred). Extensive project management experience may substitute the need for a degree.

Experience

  • High performing, credible professional, with a track record of successfully coordinating cross functional projects and teams.
  • Cultural awareness and sensitivity; ability to network and communicate with various levels of the organization.
  • Fair understanding of technical and business principles and processes of medicine manufacture and regulatory requirements attained in various functions / areas of pharmaceutical industry.
  • >6 years project management experience, of this, >2 years within similar role and complexity; experience in Health Care / Pharma Industry preferred
  • Strong planning capabilities (decision making, result oriented, challenge capability, negotiation, supporting others, stakeholder mgt, change mgt, working in a matrix organization)
  • Strong proficiency in Microsoft Excel, PowerPoint, and MS Project
  • Strong verbal communication and presentation skills
  • Flexibility and adaptability to change.
  • Learning agility and ability to work in a complex and rapidly changing environment.
  • Basic understanding of regulatory and legal requirements

Job Summary

JOB TYPE

Full Time

SALARY

$111k-138k (estimate)

POST DATE

07/15/2024

EXPIRATION DATE

08/01/2024

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