CQV Engineer

Southern Cross
Indianapolis, IN Full Time
POSTED ON 9/7/2023 CLOSED ON 10/31/2023

What are the responsibilities and job description for the CQV Engineer position at Southern Cross?

Build a rewarding career

The Spear Group is a subsidiary organization of Sparus Holdings. Sparus Holdings is a leading provider of outsourced field and professional services primarily focused on the gas and electric utility markets. Sparus goes to market under seven core brands – Southern Cross, NAFS, The Spear Group, OneVision, TruCheck, ULS, and Allegiant. Its subsidiaries provide a unique blend of differentiated, yet complementary services to offer a tightly integrated solution set for its customers while expanding its addressable market and future growth prospects.


The Spear Group hopes to present you with the next opportunity for your career. When you partner with the Spear Group for your next role, you’ll be working alongside an experienced team who truly understands the challenges of your sector. We’ll take the time to appreciate the types of projects you enjoy, as well as the work environments you thrive in. With over 30 years of experience, we have deep networks and serve top-tier companies across North America. Explore our current postings and submit your resume to start the conversation today.


Relocation available for out of state applicants


The CQV Engineer has responsibility for executing and managing equipment, facility, utility, process, primary packaging validation activities and change management activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory expectations. Additionally supports current project operations and site goal objectives and ensures compliance with regulatory, corporate, and site requirements related to their functional area.

·        Support site validation planning by writing and maintaining master plans for projects and the site including equipment, facility, utilities, processes, cleaning, packaging processes and ongoing verification for processes and cleaning (as applicable).

·        Support site lead in maintaining the process control strategy.

·        Support drafting of CSV activities for lab and manufacturing equipment.

·        Supporting on going qualification activities of VHP qualification, smoke studies, temperature mapping, room qualification, requalification.

·        Design, execute and document experiments (formulation / analytical tests etc.) for products assigned in the context of process transfer, process improvement and process validation.

·        Prepare and review appropriate GxP documentation including change requests.

·        Identify improvement options of current processes, propose business cases.

 

Salary:  Competitive Salary offerings

Benefits:  Paid Leave, 401-K, Group Medical, Dental, Vision, Life, AD&D, etc.

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EQUAL OPPORTUNITY EMPLOYER

The Spear Group, Inc. and our PEO, Oasis Outsourcing, are Equal Opportunity Employers. All personnel actions are effected without regard to race, color, sex, age, religion, national origin, disability, veteran status, or other protected status pursuant to law. As a responsible organization, we resolutely support the concept and practice of Equal Employment Opportunity. We uphold federal, state, and local civil rights laws and work to ensure that all of our personnel actions and policies are in compliance. Additionally, we recognize and value the importance and diversity of our work force and support its various cultures. The Companies are dedicated to fostering an environment that respects the dignity, rights and contributions of our employees.

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