csv / cqv engineer.

• indianapolis , indiana

• posted july 8, 2024

job details

summary

• $50 - $80 per hour

• contract

• bachelor degree

• category life, physical, and social science occupations office and administrative support occupations

• reference48420

job details

job summary:

As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

location: Indianapolis, Indiana

job type: Contract

salary: $50 - 80 per hour

work hours: 8 to 4

education: Bachelors

responsibilities:

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 Company Quality Manual and RLT Site SOPs.

qualifications:

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

skills: Project Management

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.