Validation Engineer

Title: Validation Engineer
Location: Brooksville, FL
Industry: Pharmaceutical
Salary: $80k and up depending on experience
Employment Type: Direct Placement

Client Overview:
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.

Position Overview:
The Validation Engineer will be responsible for the preparation, review, and approval of quality and validation-related documentation, ensuring compliance during manufacturing operations. This position reports to the Manager of Quality Assurance.

Responsibilities:

• Lead and perform Commissioning, Qualification, and Validation (CQV) activities in support of cGMP manufacturing, fill finish, and QC laboratories.
• Prepare appropriate documentation for assigned projects in the areas of equipment, software, process, control systems, and critical system C & Q and validation activities.
• Ensure implementation of the latest applicable regulatory trends for data integrity/security.
• Provide guidance, review/approve CSV lifecycle documents such as Validation Plans, GxP Assessments, Traceability Matrices, Risk Management Plans, and Validation Summary Reports.
• 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, and document change requests to assess their impact on validated systems.
• Identify process improvement opportunities and equipment needs for manufacturing/packaging.
• Establish and maintain good practices for aseptic environments.
• Demonstrate superior project management skills and leadership qualities.
• Be open to a flexible and fluid work environment, supporting various assignments as directed.
• Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practices.
• Support Agency, customer, and vendor audits as needed.
• Resolve protocol discrepancies and deviations, providing input on complex technical issues.
• Review vendor-generated validation protocol packages.
• Support change control deliverables.
• Generate complex protocols using a risk-based approach that meets current regulatory requirements and industry practices.

• BS/MS in Biology/Chemical/Biochemistry/Biomedical/Mechanical/Industrial Engineering.
• Minimum of 5 years of experience as a Validation Engineer.
• Proficiency in Technical writing.
• Direct experience developing, executing, and generating validation reports for pharmaceutical manufacturing and laboratory equipment.
• CSV and Cleaning validation experience (preferred).

• Employee may be required to lift or handle objects weighing up to 50 pounds for certain job duties.
• Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents.

• Must successfully complete all departmental training modules and meet the requirements as part of ongoing training.
• Must successfully complete all material handling training/verification as part of ongoing training.

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.

ADA/EOE

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