The Staffing Resource Group, Inc
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Senior Validation Engineer:
Support validation of cGMP equipment, facilities, and processes. These duties will include but are not limited to: and validation of laboratory systems, production equipment, manufacturing processes and utilities.
Essential Functions:
Education:
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
EOE/ADA
#LI-SRG
Senior Validation Engineer
Posted: 02/20/2023
2023-02-20
2023-06-03
Division: Life Sciences
Job Number: JN -022023-16448-1
State:
Job Description
Senior Validation Engineer:
- Title: Senior Validation Engineer
- Location: Grand Rapids, MI
- Industry: Pharmaceutical
- Salary: Based on Experience
- Employment Type: Direct Placement
Support validation of cGMP equipment, facilities, and processes. These duties will include but are not limited to: and validation of laboratory systems, production equipment, manufacturing processes and utilities.
Essential Functions:
- Responsible for preparing appropriate documentation for assigned projects in the areas of equipment, software, process, control system and critical system C & Q and validation activities.
- Review and approve validation protocols/reports, change control documents, work orders, and document change requests.
- Act independently with minimal supervision to conduct validation studies.
- Utilize risk assessment to identify critical areas for validation and generate test scripts accordingly.
- Proactively and regularly communicate with the project team to update on validation status.
- Identify process improvement opportunities and equipment needs for manufacturing/packaging.
- Establish and maintain good practices with regards to processes and/or internal conditions leading to an aseptic environment.
- Demonstrate superior project management skills and leadership qualities.
- Open to a flexible and fluid work environment. Work on any assignment as directed and flexibility to support limited multi-shift operations, training and testing.
- Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.
- Support Company s Core Values of Quality, Service, Collaboration, and Courage.
- Support Agency, customer, and vendor audits as needed.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Perform all other tasks, projects, and duties as assigned.
- Assist with maintaining and revising validation procedures.
- A minimum of 5 years related work experience in a pharma, biopharma, and/or biotech manufacturing environment.
- Knowledge of GAMP5, ISPE Baseline Guides for Commissioning and Qualification and ASTME2500, preferred.
- Knowledge of cGMPs for API facilities, pharmaceutical manufacturing processes, clean rooms, utility systems and packaging operations.
- Has proven the ability to meet the requirements of the essential duties and responsibilities.
- Must have proficient computer skills in Microsoft Word, Excel, and Outlook.
Education:
- Completion of a bachelor s degree in Engineering is required.
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
EOE/ADA
#LI-SRG
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Ready to embark on an exciting career journey in the vibrant city of Grand Rapids, Michigan? Explore our latest job opportunities in this dynamic region that boasts a thriving job market and a welcoming community. Known as Beer City USA, Grand Rapids is home to an array of craft breweries, stunning art galleries like the Frederik Meijer Gardens & Sculpture Park, and impressive cultural attractions such as the Grand Rapids Ballet and the Grand Rapids Symphony. With its lively downtown area, renowned restaurants serving up local delicacies like pasties and Michigan cherry pie, and picturesque outdoor spaces like Millennium Park and John Ball Zoo, Grand Rapids offers a perfect blend of urban amenities and natural beauty for professionals looking to advance their careers in a charming and growing city. Dive into our job listings and discover the opportunities waiting for you in Grand Rapids!
For more than 30 years, SRG4 has worked with clients in Fortune 100 corporations, as well as emerging and rapid growth companies, located throughout the United States and globally.
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