CSV / CQV Engineer 6 month contract Indianapolis, IN, 46268 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. • Be the go-to person in case of requests with regard to 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 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.
Ideal Background Education: Minimum: Degree in Science and Certification in Project Management (preferred). Extensive project management experience may substitute the need for a degree.
Languages: Fluent in English; Second Language preferred
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 organisation. • 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 • Fexibility and adaptability to change. • Learning agility and ability to work in a complex and rapidly changing envirnomnemt. • Basic uderstanding of regulatory and legal requirements
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $70.00/hr.
