Senior Validation Engineer
Grand Rapids, MI US
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.
- 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.
- 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.