Senior Validation Engineer
Company: The Staffing Resource Group Inc
Location: Grand Rapids
Posted on: March 19, 2023
Senior Validation Engineer:
- Title: Senior Validation Engineer
- Location: Grand Rapids, MI
- Industry: Pharmaceutical
- Salary: Based on Experience
- Employment Type: Direct Placement Position summary:
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
- Responsible for preparing appropriate documentation for
assigned projects in the areas of equipment, software, process,
control system and critical system C & Q and validation
- Review and approve validation protocols/reports, change control
documents, work orders, and document change requests.
- Act independently with minimal supervision to conduct
- 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
- 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
- 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
- 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
- Perform all other tasks, projects, and duties as assigned.
- Assist with maintaining and revising validation procedures.
Work Experience and Skills:
- 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
- Has proven the ability to meet the requirements of the
essential duties and responsibilities.
- Must have proficient computer skills in Microsoft Word, Excel,
- Completion of a bachelor s degree in Engineering is
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.
Keywords: The Staffing Resource Group Inc, Grand Rapids , Senior Validation Engineer, Engineering , Grand Rapids, Michigan
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