Engineer III - Validation Engineer

Katalyst-Healthcares-; Cincinnati (OH); On-site; USD 100,000 - 150,000; Full time

Job summary

Katalyst-Healthcares is seeking a Validation Engineer to lead validation activities in a clinical packaging area. You will oversee capital projects, coordinate with operations, engineering services, and vendors, and manage the Validation Master Plan to ensure compliance with standards and quality expectations.

The role requires strong knowledge of validation documents (VMS) and collaboration with Quality and Operations to optimize processes, improve efficiency, and maintain product quality

Qualifications

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

Responsibilities

• Manage all departmental capital projects and coordinate services.
• Lead equipment, facility, utility and cleaning validation activities.
• Maintain the Validation Master Plan and Validation Change Control.
• Identify opportunities to reduce costs and increase capacity via process improvements.
• Represent department in quality audits regarding validation and engineering compliance.
• Supervise engineering technicians and manage resource allocation.
• Collaborate with Operations and Quality through Validation Review Boards.

Skills

Validation

Engineering

Quality systems

Process improvement

Education

BS in engineering

Tools

VMS

Client systems

Engineering standards

Job description

Job Description

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 the operations, engineering services, and third party vendors for executing activities within 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.

Roles and 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.

Education and Experience

• 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.