Principal Validation Engineer - Wilson, United States - Insight Global

Insight Global Wilson, United States

3 weeks ago

Description

The Principal Validation Engineer plays a pivotal role as a subject matter expert within manufacturing operations, fostering collaboration across quality, regulatory, manufacturing, engineering, and global R&D teams.

This individual is entrusted with providing technical support for equipment/system validation and requalification, while actively participating in equipment enhancement initiatives to bolster compliance and performance in alignment with regulatory standards.

Responsibilities
Direct validation team members and contractors as needed, project managing the implementation of developmental initiatives, and spearheading process improvements and best practices
Demonstrate a comprehensive understanding of cGMPs alongside obtaining certification to access controlled areas of the plant
Encompass mentorship and guidance for other team members, emphasizing the importance of outstanding verbal and written communication skills to facilitate seamless interaction with various departments at local, regional, and global levels
Provide comprehensive technical guidance to all manufacturing facilities and third-party manufacturing departments, ensuring the adoption of best practices to enhance manufacturing processes' robustness and efficiency
Employ multidisciplinary approaches and technical principles to devise innovative solutions for complex challenges, advising senior management on appropriate courses of action
Effectively communicate plant issues, tasks, and project updates with cross-functional teams, facilitating the scaling up of processes, introduction of new equipment and procedures, and validation of manufacturing batches
Provide technical support for investigations, action plans, and regulatory compliance efforts, while mentoring departmental staff and fostering their professional development
Conduct validation activities, including deviations and investigations to identify root causes and define corrective and/or preventative actions (CAPAs) , to ensure compliance with regulatory requirements
Review validation documentation and facilitate requirements with external partners and vendors as necessary
Serve as an approver for qualification, validation, and periodic review protocols and reports, demonstrating a commitment to upholding quality standards

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day.

We are an equal opportunity/affirmative action employer that believes everyone matters.

Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances.

If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to .

To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:
.

Required Skills & Experience

Bachelor's degree in science or engineering (STEM)
8+ years of equipment validation exp within sterilization, filling, packaging, utilities, or facilities
Experience in cGMP, industry guidance, aseptic techniques, CA/PA, root-cause analysis, risk assessment and investigation tools and techniques
Knowledge of parenteral product development, manufacturing processes, validation, cGMP's and FDA regulations for the pharmaceutical industry

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching.

Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

Validation Engineer

2 weeks ago

ND Global Consulting Services Inc Wilson, United States

Job Description · Job Description · Job Description: · Develop and execute Qualification deliverables for process equipment, CIP and SIP including but not limited to Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Trace Matrices, Test Execution, Summary reports. Equipme ...
Principal Validation Engineer

2 weeks ago

Insight Global Wilson, United States

Our client, an industry leading pharmaceutical company, is looking for a Principle Validation Engineer to lead their team in Eastern, NC. The Principal Validation Engineer plays a pivotal role as a subject matter expert within manufacturing operations, fostering collaboration acr ...
principal validation engineer

2 weeks ago

Fresenius Kabi USA, LLC Wilson, United States

Job Summary · Responsibilities · Additional Information · We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, · disability,401K · with company match, andwellness program. · Fresenius Kabi is an Equal · ...
Diesel Technician/Mechanic II

3 days ago

Penske Truck Leasing Rocky Mount, United States Full time

1920 fenner road rocky mount nc 27804 What's the Job? · Ready to move your career forward? As a Technician at Penske, you'll do exactly that. Here, you'll perform preventative maintenance and repairs of all levels on the newest and best maintained fleet of vehicles in the industr ...
Diesel Technician/Mechanic II

1 week ago

Penske Truck Leasing Rocky Mount, United States Full time

1920 fenner road rocky mount nc 27804 What's the Job? · Ready to move your career forward? As a Technician at Penske, you'll do exactly that. Here, you'll perform preventative maintenance and repairs of all levels on the newest and best maintained fleet of vehicles in the industr ...
Junior Reliability Engineer

2 days ago

Jones Lange Lasalle, Inc. Wilson, United States

The Junior Reliability Engineer is responsible for performing data validation around assets (HVAC Equipment, Electrical Equipment, etc.) that are managed by both Mobile and Static Facilities Management Technicians at all managed facilities within o Reliability Engineer, Liability ...
Automation Delta V Engineer

3 days ago

Piper Companies Wilson, United States

Piper Life Sciences is actively seeking a Automation and Controls Engineer to join a biotechnology manufacturing organization specializing in Wilson, North Carolina area. The Automation and Controls Engineer will be leading projects for Rockwell integration, automation validation ...
Project Engineer, Pharmaceutical Packaging Line

1 week ago

Katalyst HealthCares & Life Sciences Wilson, United States

Responsibilities: Project Management in facilities/engineering · Work with design engineering firm during design phase · Work with Operations to specify packaging equipment for purchase. · Manage contractors and vendors to coordinate construction and equipment install. · Wor ...
Driver License Examiner I

2 weeks ago

State of North Carolina Wilson, United States

Salary Grade: NC03 Salary Range: $31,200 - $50,298 · New hire applicants will be hired at a hiring rate of $42,103 · This is an anticipated vacancy. · This position with NCDOT offers full State Benefits, competitive salaries and many career development opportunities. · This Pos ...
Master Technician

6 days ago

Fresenius Kabi US Wilson, United States

Job Summary · POSITION SUMMARY · The Master Technician provides direct engineering and maintenance support for facility and utility processes and equipment to support the manufacturing of pharmaceutical products in a cGMP compliant manner. He/She will collaborate with multiple si ...
Heavy Equipment Mechanic

5 days ago

Fred Smith Company Wilson, United States

Fred Smith Company is currently searching for a Heavy Equipment Mechanic for our Wilson location. The successful candidate will have at least two years' experience in heavy equipment maintenance/repair and extensive knowledge of diesel engines. A valid NC drivers license with a p ...
Mobile HVAC

6 days ago

JLL Wilson, United States

JLL supports the Whole You, personally and professionally. · Our people at JLL are shaping the future of real estate for a better world by combining world class services, advisory and technology to our clients. We are committed to hiring the best, most talented people in our indu ...
Project Engineer

2 weeks ago

The Rockridge Group Wilson, United States

Job DescriptionJob Description · TITLE: PROJECT ENGINEER - PHARMACEUTICAL PACKAGING LINE · Job Summary: · Responsible for Project planning, execution and closure on the installation of new packaging equipment. The Project Engineer must ensure projects are carried out efficient ...
sr project engineer

2 weeks ago

Fresenius Kabi USA, LLC Wilson, United States

Job Summary This position will manage implementation of projects related to the manufacturing of terminal sterilized pharmaceutical bags. · Will ensure inclusion of existing site operation, facility and engineering team members in the learning and design process for those new sy ...
Electrical & Maintenance Mechanic

6 days ago

Schweitzer-Mauduit International, Inc. Wilson, United States

Mativ is a global leader in specialty materials headquartered in Alpharetta, Georgia. The Company offers a wide range of critical components and engineered solutions to solve our customers' most complex challenges. With over 7,500 employees worldwide, we manufacture on four conti ...
Electrical & Maintenance Mechanic

6 days ago

MATIV HOLDINGS INC Wilson, United States

· Mativ is a global leader in specialty materials headquartered in Alpharetta, Georgia. The Company offers a wide range of critical components and engineered solutions to solve our customers' most complex challenges. With over 7,500 employees worldwide, we manufacture on four co ...
Maintenance Helper

2 weeks ago

Cushman & Wakefield Inc Wilson, United States

Job Title · Maintenance Helper · Job Description Summary · Position Summary · The Maintenance Helper assists with the performance of a variety of non-technical, non-licensed mechanical, electrical, maintenance, painting, carpentry, custodial, plumbing, general repair, and other h ...
Senior Controls Engineer

1 week ago

Bridgestone Americas Wilson, United States

**Company Overview** · Wherever you work and whatever role you fill, when you represent the Bridgestone name you know that you are a valued teammate who is part of our larger mission to Serve Society with Superior Quality. We start by offering each teammate more than just a sala ...
Senior Controls Engineer

1 day ago

Bridgestone Americas Wilson, United States

Bridgestone Americas · Senior Controls Engineer · Wilson , · North Carolina · Apply Now · Wherever you work and whatever role you fill, when you represent the Bridgestone name you know that you are a valued teammate who is part of our larger mission to "Serve Society with Su ...
Senior Controls Engineer

2 weeks ago

Bridgestone Americas Wilson, United States

Company OverviewWherever you work and whatever role you fill, when you represent the Bridgestone name you know that you are a valued teammate who is part of our larger mission to "Serve Society with Superior Quality." We start by offering each teammate more than just a salary. We ...