Senior Cleaning Validation Engineer

cGMP ConsultingMadison, WI

$140,000 - $200,000 / year

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Overview

Schedule

Full-time

Education

Engineering (PE)

Career level

Senior-level

Compensation

$140,000-$200,000/year

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Job Description

About Us

At cGMP Consulting, we specialize in providing expert validation, qualification, and compliance services to the life sciences industry. Our team works with clients to ensure their facilities, equipment, and processes meet regulatory standards, enabling the safe and efficient production of pharmaceuticals.cGMP Consulting is based in Lake Forest, IL. Our main client locations are Melrose Park, IL, North Chicago, IL, Waukegan, IL and Pleasant Prairie, WI.

Position Summary

cGMP Consulting is seeking an experienced and driven individual to lead and manage cleaning validation activities, prepare and execute protocols, and act as SME regarding cleaning development and validation. This senior-level role offers significant autonomy, leadership responsibility, and the opportunity to influence operations in a fast-paced, GMP-compliant manufacturing environment.

The ideal candidate will have a proven ability to lead cross-functional initiatives, navigate complex troubleshooting challenges, drive change management efforts, and ensure timely and thorough completion of protocols. This candidate has deep experience in current Good Manufacturing Practices (cGMP), along with a solid understanding of FDA regulations, and international compliance standards.

Responsibilities

The essential functions include, but are not limited to the following:

Design and develop cleaning procedures for new product and manufacturing equipment.

Provide technical support to cleaning activities associated with the manufacturing process.

Lead the cleaning validation program and activities

Knowledge of cleaning agents and establishment of sound cleaning practices within new or refurbished manufacturing rooms and sampling suite areas.
Design and support implementation of cleaning strategies for product transfer projects and product development projects.
Investigate and conduct troubleshooting or root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non validated or under developed cleaning procedures.
Lead enhancement of cleaning practices and review and approve work instructions.
Support the periodic review of cleaning validation studies.
Perform successful resolution of incidents and deviations related to cleaning activities.
Issue change controls required for implementation of cleaning procedure changes.

Requirements

Minimum Bachelors’ degree in Engineering, Science, or a related field of study.
4+ years’ experience in a GMP manufacturing environment, including cleaning validation. Must be familiar with regulatory (FDA) requirements.
Expertise in multiple areas: cleaning validation, continuous process improvement, and/or qualification of aseptic filling or formulation equipment/processes.
Advanced critical thinking and technical writing skills.
Strong organizational, communication, and interpersonal skills.

Compensation and Benefits

Expected pay range per year: $140,000-$200,000 USD
Expected benefits include: Medical, Dental, Vision, PTO, 401K

Disclaimer

The duties and responsibilities described are not a comprehensive list and additional tasks may be assigned to the employee from time to time; or the scope of the job may change as necessitated by business demands. All duties and responsibilities are subject to possible modification to reasonably accommodate individuals with disabilities. The requirements listed are the minimum levels of knowledge, skills, or abilities necessary to perform this job successfully. The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations as applicable.

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FAQs About Senior Cleaning Validation Engineer Jobs at cGMP Consulting

What is the work location for this position at cGMP Consulting?

This job at cGMP Consulting is located in Madison, WI, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at cGMP Consulting?

Candidates can expect a pay range of $140,000 and $200,000 per year.

What employment applies to this position at cGMP Consulting?

cGMP Consulting lists this role as a Full-time position.

What experience level is required for this role at cGMP Consulting?

cGMP Consulting is looking for a candidate with "Senior-level" experience level.

What is the process to apply for this position at cGMP Consulting?

You can apply for this role at cGMP Consulting either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.