- Manage a team of Principal, Senior and entry-level Validation Engineers whose responsibility is to perform qualification, re-qualification, and periodic review of equipment, processes and utilities.
- Creates, reviews and maintains validation protocols, reports and related documents ensuring accuracy and completeness.
- Support investigations (OOS, IIR, PIR, etc.) as required.
- Review and update SOPs to ensure appropriate content.
- Ensure that employee training is performed and maintained.
- Support plant in the development of process improvements and efficiency.
- Ensure that the Validation department operates within the budget provided by Senior Management.
- Ensures compliance with FDA and other relevant regulatory requirements and standards.
- Ensure department personnel are aware of Environmental and Energy Management System including Environmental and Energy Policy
- Responsible for ensuring that Health, Safety and Environmental requirements are met under the requirements of ISO 14001 Environmental Management System and ISO 50001 Energy Management.
- Responsible for the overall completion of validation studies including reviewing, scheduling, and overseeing the process (Utility, equipment, cleaning, process, computer, and new products) to include protocol preparation, scheduling, protocol execution, and review / approve final report preparation.
- Represents the Validation department at the location.
- Overall accountability for ensuring all the equipment meets qualification and re-qualification per regulatory agency standards and company SOPs.
- All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per roles and responsibilities.
- Bachelors degree in a Science or Engineering field of study.
- 5+ years of related experience in a cGMP facility.
- 1+ year of management experience.
- Installation, operational and Performance Qualification protocol generation and execution experience.
- PC literate with standard office application (Word, Excel, PowerPoint, Project, Access) competency.
- Knowledge and understanding of cGMPs, industry guidance and best practices, and aseptic techniques.
- Understanding of statistical analysis tools and methods.
- Good communication skills and leadership skills are required.
-
Validation Manager
1 week ago
Rbw Consulting Chicago, United StatesRBW are eagerly searching for experienced Validation Managers to join an expanding CDMO. Active in the market for 40 years, they present a variety of product across Sterile/Non-Sterile categories, collaborating with forward-thinking Pharma and Biotech partners. · With the expans ...
-
Validation Manager
1 week ago
Abbott Laboratories company North Chicago, United StatesAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
-
Validation Manager
1 week ago
Abbott North Chicago, United StatesAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...
-
AVP, Validation Manager
2 weeks ago
Synchrony Chicago, United StatesJob ID: E2402229 · Job Description: · Role Summary/Purpose: · As AVP, Validation Manager, you will be responsible for certifying the accuracy and completeness of documentation, scope, and path approval relative to remediations in addition to other initiatives for the Remediation ...
-
Product Validation Engineering Manager
2 days ago
Lanco Hazel Crest, United StatesMaterial Handling - We bring the muscle.The most complete lifting company in the world, Lanco represents four iconic, world-class heavy equipment manufacturers, mobile crane dealerships across US and Canada, the largest parts and service network in North America, and factory-auth ...
-
Phoenix Industries Melrose Park, United StatesMedical Director Central Laboratory Location: Melrose Park Employment Type(s): Full-time Your new workplace: Hospital for specialized care and academic teaching hospital with approximately [insert number] beds in the Schleswig region. The central laboratory is equipped with state ...
-
Milk Equipment Service Technician
6 days ago
Lely Melrose, United StatesMilk Equipment Service Technician · Leedstone is actively seeking an experienced, full-time professional for our equipment team in Plainview, MN. The person who fills this position will assist in the installation and service of milk harvesting equipment, including automated milk ...
-
Senior Project Manager, WMS Software
1 day ago
Interlake Mecalux, Inc. Melrose Park, United StatesWe are hiring a dynamic, customer-focused Project Manager to work out of our Melrose Park, IL corporate office. This role will support the implementation of our WMS software, Easy WMS, at our customer's sites all over the US. · Major responsibilities include, but are not limited ...
-
Quanta US Melrose Park, United StatesCompany Overview: Our client is a thriving and established Italian printing company with an American branch in the Chicago metropolitan area. They position themselves as a medium-sized company in robust growth. With a rich industrial tradition and a global presence, our client sp ...
-
Soliant Melrose Park, United StatesMinimum 1+ years special education experience required. · We are seeking a dedicated and flexible Special Education Teacher to serve as a Long-Term Substitute (LTS) and Floater for Family and Medical Leave Act (FMLA) absences throughout the school year. The ideal candidate will b ...
-
Project Construction Manager
4 weeks ago
Olsson Melrose Park, United States Full timeJob Description · This role will include being onsite at multiple locations and will require significant travel. Travel expectations for this position are estimated at 90% - 100% and will require visiting different projects across multiple states. We are seeking candidates whose ...
-
Soliant Melrose, United StatesMinimum 1+ years special education experience required. · Position: Special Education Teacher · Location:Melrose, NM · Start Date: 8/8/2024 · Hours:Full Time · Our well-established staffing organization and its affiliates are proud to partner with school districts in the Melrose, ...
-
Child Soccer Skills Coach
1 week ago
Soccer Shots - Metro North Melrose, United States Part timeSoccer Shots is an engaging children's soccer program emphasizing character development. Our caring team positively impacts children's lives on and off the field through best-in-class coaching, curriculum, and communication. · WHAT YOU GET: $25 ($20 during training) per hour minu ...
-
Outside Sales Representative Melrose Park, IL
2 weeks ago
UniFirst Corporation Melrose Park, United StatesReady to join a dynamic and growing organization with unlimited potential? · UniFirst is seeking an Outside Sales Representative to join our team · Work for an international leader in the $18 billion dollar garment services industry. We currently employ 14,000 team partners wh ...
-
Job Title: School Psychologist
2 weeks ago
Soliant Maywood, United StatesMinimum 1+ years school psychologist experience required. · Location: Maywood, IL · About Us: · We are a nurturing and inclusive school community dedicated to providing exceptional education and support to our students. Our mission is to foster the academic, social-emotional, and ...
-
Loyola University Health System Maywood, United StatesEmployment Type: Part time Shift: Rotating Shift Description: Employment Type: · Casual · Shift: Midnights · Loyola Medicine, a member of Trinity Health, is a nationally ranked academic, quaternary care system based in Chicago's western suburbs. Loyola Medicine Transport is ...
-
Client Account Specialist
3 weeks ago
Hackensack Meridian Health Maywood, United States Full timeOur team members are the heart of what makes us better. · At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitiv ...
-
Operations Supervisor
1 week ago
Pacific Rail Services Northlake, United States Full timePacific Rail Services is the industry leading lift contractor / rail management service for all Class 1A railroads in the country. We are looking for driven / energetic operations supervisors at our Union Pacific Global II terminal. · Requirements:Applicants must possess strong c ...
-
Director Quality Management
1 week ago
Kindred Hospital Chicago Northlake Northlake, United StatesDescription · What makes Kindred Healthcare a great place to work? Ourpeople, of course Our clinicians answer this special calling becausethey have a fundamental, internal drive to directly help people. In return, weserve, develop and respect our employees in environments crea ...
-
Corporate Account Executive
2 days ago
The Custom Companies, Inc. Northlake, United StatesThe Corporate Account Executive will be responsible for developing and fostering professional relationships with existing and potential clients always seeking to maintain and increase customer satisfaction. You will be expected to increase the territory's revenue by prospecting n ...
Validation Manager - Melrose Park, United States - cGMP Consulting Inc
4 weeks ago
![Default job background](https://contents.bebee.com/public/img/bg-user-ex-1.jpg)
Description
Job Description
cGMP Consulting is looking for an individual to manage the Validation personnel. This individual will oversee validation activities related to equipment and computerized system qualifications and re-qualifications. The ideal candidate for this job is resourceful, independent, organized, and capable of working in a fast-paced environment.
This position is direct hire.
Responsibilities
Position skills and requirements:
Powered by JazzHR