Validation Engineer - Decatur, United States - Infojini Inc

Infojini Inc Decatur, United States

3 weeks ago

Description

Job Title – Cleaning Validation Engineer

Location – Decatur, IL 62522

Duration – Full time position

Shift Hours – MON-FRI

Job description:

• The successful candidate is an SME in cleaning and sanitization effectiveness validation and has knowledge of equipment and process validation. The Engineer prepares product contact surface cleaning and room and equipment sanitization effectiveness validation, process and equipment validation protocols, protocol final reports and procedural documentation.

• Responsibilities include coordinating validation activities with departments and personnel and maintaining the cleaning validation processes and procedures.

• As the cleaning validation SME, the candidate is knowledgeable in cleaning validation concepts, practices, procedures and leads and instructs others supporting cleaning validation deliverables.

Essential Duties & Responsibilities:

• Cleaning Validation Responsibilities Writing and reviewing cleaning and sanitization procedures and maintaining the Cleaning Validation Master Plan.

• Execution of cleaning validation protocol activities and sample collection.

• Responsible for adherence to FDA guidance and regulatory requirements and Rising Pharma Validation Master Plans.

• Preparing, reviewing, and executing related validation studies such as extraction and recovery studies for product contact surfaces and equipment surfaces.

• Preparing and executing cleaning development protocols including lab scale, full scale spray coverage testing, and full-scale cleaning recipe and procedure development.

• Preparing risk assessment and reports summarizing data and determination of cleaning matrix and critical cleaning parameters for validation. Assess new products being introduced to the site for alignment within the approved cleaning matrix.

• Assessment, preparation, and execution of sanitization effectiveness study protocols with Microbiology Lab for active and new sanitizing agents on room and work surfaces.

• Assisting in investigations, i.e., deviations during the execution of protocols and/or continuous monitoring activities and providing documentation to support the findings of the investigation.

• Lead development projects when modifications are required and implementation of new cleaning equipment/processes.

• Preparing SOPs and providing training to staff on the cleaning validation approach procedures.

• New cleaning equipment URS, FAT, SAT, IQ, OQ and PQ document generation and execution.

• Perform periodic cleaning validation verification studies.

• SME for presentation of cleaning validation to Regulatory (FDA), internal and external auditors.

• Equipment and Process Validation Responsibilities Scheduling, planning and execution of equipment and process qualifications meeting approved schedules.

• Coordinating validation activities with other departments. Experience with Equipment and Instrument Standards used for validation executions.

Education and Experience:

• Minimum of a bachelor's degree in a scientific discipline (e.g. Microbiology, Biology, Engineering or Chemistry); and at least five (5) years of cleaning validation in a pharmaceutical operation or relevant experience.

Company Overview:

• Infojini Consulting is a Staffing and Recruitment company and incorporated in Baltimore, MD.

• Infojini caters various hospitals, health & wellness centers, pharmacy, and medical facilities over fifty states across the United States.

Cleaning Validation Engineer

3 weeks ago

Unizon Technology LLC Decatur, United States

Job Description · Job DescriptionTitle: Cleaning Validation Engineer · Work Location: Decatur, IL · Employment Type: Full Time · Position Summary: · The successful candidate is an SME in cleaning and sanitization effectiveness validation and has knowledge of equipment and process ...
Validation Engineer

3 weeks ago

Infojini Decatur, United States

Job Title Cleaning Validation Engineer · Location Decatur, IL 62522 · Duration Full time position · Shift Hours MON-FRI · Job description: · The successful candidate is an SME in cleaning and sanitization effectiveness validation and has knowledge of equipment and process va ...
Development Engineer Electrical Engineering

1 week ago

Omega Ventures Decatur, United States

On behalf of our client, we are looking for a Development Engineer in the field of Electrical Engineering in Decatur. · Your responsibilities · Planning and designing complex systems for measurement technology · Development of components for serial production and assembly · Creat ...
Staff Engineer Principal

4 weeks ago

DeKalb County Decatur, United States

Salary Range: $71,505 - $110,835 · ; ; ; ; Only Watershed Management Employees May Apply · ; ; Purpose of Classification:; ; The purpose of this classification is to lead a team of engineers performing professional civil engineering tasks in support of capital projects, plan ...
Engineer Review Officer, Senior

3 weeks ago

DeKalb County Decatur, United States

Salary Range: $58,662 - $94,446 · Essential Functions: · The following duties are normal for this position. The omission of specific statements of the duties does not exclude them from the classification if the work is similar, related, or a logical assignment for this classifi ...
Engineer Review Officer

2 weeks ago

DeKalb County Decatur, United States

Salary Range $54,927 - $88,433 · Purpose of Classification: · The purpose of this classification is to review residential and commercial land development permits to ensure compliance with local, state, and federal codes, policies, rules, regulations, and standards. · Essentia ...
Plant Shift Supervisor

3 weeks ago

DeKalb County Decatur, United States

Salary Range: $54,927 - $88,433 · Purpose of Classification: · The purpose of this classification is to serve as the shift supervisor for water and wastewater facilities in compliance with federal, state, and local requirements for the operation of water treatment, distribution ...
Engineer Review Officer

4 weeks ago

DeKalb County Decatur, United States

Salary Range $54,927 - $88,433 · Purpose of Classification: · The purpose of this classification is to review residential and commercial land development permits to ensure compliance with local, state, and federal codes, policies, rules, regulations, and standards. · Essentia ...
Auto Technician Opportunities

17 hours ago

Belle Tire Decatur, United States

Text "Belle" to 22633 to apply · $5,000 Sign On Bonus. (Bonus of $1,250.00 which will be paid every 3 months for your first year of employment. Note that you must be employed and maintain a full-time status at the time the bonus is paid in order to be eligible.) · Are you a skill ...
Building Inspector

3 weeks ago

DeKalb County Decatur, United States

Salary Range: $48,389 - $77,907 · These openings are one for HVAC and two electrical Building Inspectors in the Planning & Sustainability department. · Essential Functions: The following duties are normal for this position. The omission of specific statements of the duties does ...
Mechanical Engineer 4

4 weeks ago

United Launch Alliance Decatur, United States

Your Role: · What you'll be doing The Payload Accommodations IPT develops, designs, and tests structural/mechanical mission-specific and standard interface solutions required to integrate payloads onto Atlas V & Vulcan Centaur launch vehicles. The function develops primary and ...
Estimator/Project Manager

5 days ago

The Kelly Group Decatur, United States

The Kelly Group is seeking an Estimator/Project Manager for its Decatur, Illinois, location. Candidates with 1 to 3 years of estimating/project management experience, preferably in the construction industry, are preferred. Recent graduates or candidates nearing completion of a de ...
Building & Fire Plans Examiner

3 weeks ago

DeKalb County Decatur, United States

Salary Range: $52,124 - $83,920 · This opening is within the Fire Rescue Department · Purpose of Classification: · The purpose of this classification is to review and coordinate all proposed construction documents in compliance with local, state and federal building, structur ...
GIS Specialist

3 weeks ago

DeKalb County Decatur, United States

Salary Range: $40,916 - $65,875 · Purpose of Classification: · The purpose of this classification is to create and revise maps showing deeds and plats and to support mapping functions by providing analysis, research, and customer service. · Essential Functions: · The followi ...
Building Official

3 weeks ago

DeKalb County Decatur, United States

Salary Range: $84,812 - $136,548 · Essential Functions: · The following duties are normal for this position. The omission of specific statements of the duties does not exclude them from the classification if the work is similar, related, or a logical assignment for this classi ...
Police Helicopter Pilot

3 weeks ago

DeKalb County Decatur, United States

Pay Range: Negotiable FLSA Status: Non-Exempt · This classification is safety-sensitive, subject to random drug testing in accordance with the County's Drug & Alcohol Policy. · Essential Functions: · The following duties are normal for this position. The omission of specific sta ...
Mechanic I

6 days ago

Primetals Technologies Decatur, United States

As pioneers at heart, we explore what's next in metals production. We are driven to pioneer new solutions that will define tomorrow's world of metals. We aim high, we try hard, and we persevere. Our curiosity fuels our passion to find new frontiers. It is what gets us up in the m ...
Plant Operator Trainee

3 weeks ago

DeKalb County Decatur, United States

Salary Range: $17/hour - $25.88/hour · Purpose of Classification: · The purpose of this classification is to operate water and wastewater treatment facilities in compliance with federal, State and Local regulations for the operation of water treatment, distribution, storage fac ...
Detailer (flat rate) 540060 (Decatur, AL)

2 weeks ago

Teph Seal Decatur, United States

Overview · FLAT RATE Detail Shop Position(s) Available. · Are you a team player who is focused on providing exemplary customer service and who performs well in a fast paced work environment? · Looking for the following position: · Detail Specialist 1 - Some experience · Detail ...
Information Technology System Architect

1 week ago

DeKalb County Decatur, United States

Salary Range: $77,339 - $124,516 · Purpose of Classification: · The purpose of this classification is to exercise technical management over multiple technical functions, platforms, technologies, conceptual designs, or applications involving systems architecture, systems applic ...