Validation Engineer

Spectraforce Technologies, Inc.; Cincinnati (OH); On-site; USD 83,000 - 124,000; Part time

Job summary

Spectraforce Technologies, Inc. is seeking a Validation Engineer in Cincinnati, OH to lead validation, maintenance, and engineering activities within the clinical packaging area.

You will collaborate with operations, engineering services, and external vendors to ensure equipment, facilities, and utilities meet quality standards. The role requires a BS in engineering and 5+ years in validation/engineering in pharma, with experience in validating documents and understanding regulatory

Qualifications

• BS in engineering and 5+ years in validation/engineering within the pharmaceutical field.
• Experience creating and executing validation documents in VMS.
• Familiarity with Client engineering and financial systems.
• Understanding of Client Engineering Standards and pharmaceutical packaging equipment.

Responsibilities

• Lead maintenance, engineering, and validation activities in the clinical packaging area.
• Coordinate with operations, engineering services, and third-party vendors.
• Manage validation documentation and Validation Master Plan (VMP).
• Interface with area managers to balance capacity and cost reductions.
• Ensure validation documents are complete and reviewed for quality and compliance.
• Investigate and resolve validation-related issues and drive quality improvement projects.
• Represent department in internal and external quality audits.

Skills

Validation engineering

Pharmaceutical knowledge

Education

Bachelor's Degree in Engineering

Job description

Title: Validation Engineer

Duration: 06 Months

Location: Cincinnati, OH 45209

The Validation Engineer functions as the lead for all maintenance, engineering, and validation activities within the clinical packaging area. Equipment, facility, utilities, and cleaning are within the scope of responsibility. The incumbent will be the primary liaison with operations, engineering services, and third party vendors for executing activities within the area of responsibility. The incumbent will also be responsible for the management of the area Engineering Technician. All responsibilities should be executed in a manner to ensure that product quality is maintained at the appropriate level to meet R&D and Corporate Quality Standards/Expectations.

Responsibilities

• Manage all departmental capital projects and miscellaneous engineering activities. Work with in-house functional support and outside vendors to coordinate required services.
• Manage all equipment, facility, utility and cleaning validation activities.
• Maintain the Validation Master Plan (VMP) as appropriate. Responsible for Validation Change Control documentation and managing the electronic tracking system.
• Identify and implement opportunities to reduce costs, increase flexibility, and generate additional capacity through process improvement initiatives. Interface with area managers from the Operations and Quality functions through the Validation Review Boards.
• Ensure the integrity, quality, adequacy, and appropriateness of validation documentation through comprehensive document review.
• Ensure thorough investigation and timely resolution of issues related to equipment, facilities, and utilities. Manage validation related, quality improvement projects to foster R&D compliance to regulatory, corporate and department requirements.
• Represent department in quality audits, both internal and external, in regards to validation and engineering compliance.
• Cultivate and foster strong working relationships with packaging operations and engineering validation disciplines.
• Initiate change requests (CR) for Standard Operating Procedures (SOP) in support of equipment and operations processes.
• Supervise FTE engineering technicians and contract validation engineering as needed. Ensure employee resource allotment and workload requirements are balanced to meet the forecasted needs of the business.
• Partners with all levels of key business functions to ensure packaging equipment has the functionality and is equipped to support new and ongoing clinical studies. Responsible for ensuring equipment reliability expectations are achieved in a high-throughput, clinical packaging facility.
• Continually evaluates and balances short term production support needs with long term strategic objectives of the department.

Qualifications

• Bachelor's Degree, a BS in an engineering discipline.
• 5+ years combined work experience in validation and/or engineering positions within the pharmaceutical area.
• Knowledge/experience in creating and executing validation documents in VMS.
• Knowledge/experience in Client engineering and financial systems.
• General understanding of Client Engineering Standards and Specifications.
• General understanding of pharmaceutical packaging equipment