USA - Team and Project Support - Artech LLC
Indianapolis, IN 46268
About the Job
Job Title: CSV / CQV Engineer
Location: : Indianapolis, IN 46268
Duration: 06 Months (possible extensions)
Type: Contract
Job Description:
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 Client 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.
Be the go-to person in case of requests about cleanroom or clean utilities.
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 Client 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 Client Quality Manual and RLT Site SOPs.
Ideal Background
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 Client 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
Location: : Indianapolis, IN 46268
Duration: 06 Months (possible extensions)
Type: Contract
Job Description:
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 Client 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.
Be the go-to person in case of requests about cleanroom or clean utilities.
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 Client 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 Client Quality Manual and RLT Site SOPs.
Ideal Background
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 Client 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
Source : Artech LLC