Sr Validation Engineer
Brooksville, FL 34604 US
Senior Validation Engineer
Title: Senior Validation Engineer
Location: Brooksville, FL
Salary: 90K and up depending on experience
Employment Type: Direct Placement
Our client is a US-based sterile injectable manufacturer of parenteral drugs with a world-class facility focused on ready-to-use pre-filled syringes and vials. The company's product line includes small molecule 505(b)(2) NDA and 505(j) ANDA syringe and vial products, and it serves as an outsourced contract manufacturing partner for strategic pharmaceutical companies.
The Senior Validation Engineer will be responsible for the preparation, review, and approval of quality and validation related documentation and ensuring compliance during manufacturing operations. This position reports to the Manager of Quality Assurance.
The Senior Validation Engineer leads and performs Commissioning, Qualification, and Validation (CQV) activities in support of cGMP manufacturing, fill finish, and QC laboratories. 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. Project management and support of validation and quality system projects.
- Utilize risk assessment to identify critical areas for validation and generate test scripts accordingly.
- Review change control documents, work orders, document change requests for assessing impact on validated systems. 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 Agency, customer, and vendor audits as needed.
- Resolves protocol discrepancies and deviations and provides inputs to complex technical issues.
- Reviews vendor-generated validation protocol packages
- Supports change control deliverables
- Responsible for the generation of complex protocols using a risk-based approach that meets current regulatory requirements and industry practice
- Minimum of 10 years of experience worked as a Validation Engineer
- BS/MS Biology /Chemical/BioChem/ BioMed/Industrial Engineering
- Strong technical writing including protocol generation, deviation investigation and generation as well as report writing is required. The candidate must be a team player, who thrives in a team environment, but also has the ability to work on their own.
- Must be proficient in Technical writing.
- Must have direct experience developing, executing and generating validation reports for pharmaceutical manufacturing and laboratory equipment, including hands on experience with cleaning validation.
- Requires a thorough understanding of 21 CFR Part 11, EU Eudralex Vol 4 Annex 11, ICH Q9/10 requirements and ASTM E2500, GAMP 5 principals, and any other industry specific pharma provisions as they apply to systems management and deployment.
- Hands on Cleaning Validation experience required. Hands on CSV experience preferred.
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