Senior Validation Engineer (Level III)

About the role

Performance Validation is seeking a Senior Validation Engineer/Specialist (Level III) to join our team in Indianapolis, IN. This is the level where your technical judgment becomes the deliverable. Clients will ask you what the validation approach should be, and you will answer with consulting recommendations grounded in deep knowledge of industry standards, solving the complex technical problems that do not have a clean answer. You will work with one or more local or regional customers within your core area of expertise, in a team or independently, meeting defined objectives against an established timeline. Much of this happens in a creative environment where there is no template and no standard form. You will write the deliverable, raise the quality bar through peer review, and help others develop written materials that hold up. It is also a leadership role in the fuller sense. Level III engineers provide management and technical leadership across validation, engineering, compliance, and scientific activities, lead small project teams or independent operations on time and within budget, and mentor less experienced members of the team. You will also contribute to business development in an ongoing way, developing leads and repeat business through your performance, professional activities, and networking. At a 100% employee-owned company, that is not someone else’s revenue. The work you do here builds something you own a piece of through stock ownership and biannual profit share. This position reports directly to the Site Manager and you will be assigned to one or more project teams headed by a Project Leader.

Responsibilities

• Provide consulting recommendations to clients based on extensive knowledge and application of industry standards.
• Apply broad knowledge of industry requirements, complete challenging technical work, and provide effective solutions to complex technical issues.
• Attain and maintain proficiency within a given technical specialty.
• Contribute to the success of project teams by providing technical expertise.
• Write and develop deliverables in a creative environment where no template or standard form exists.
• Demonstrate high quality of deliverables and work, proficiency in peer review, and strong technical writing skills.
• Assist others in developing written materials in accordance with existing requirements.
• Provide management or technical leadership on a variety of validation, engineering, compliance, scientific, and related activities.
• Lead small project teams or independent operations effectively, on time and within budget, communicating project status and other critical project information clearly.
• Understand and apply competency in PV’s project management philosophy.
• Contribute meaningfully to business development on an ongoing basis, including developing leads and repeat business through performance, professional activities, and networking.
• Stay conversant with the full range of services Performance Validation provides, and discuss them at a general level with clients.
• Mentor less experienced resources.

Requirements

• Bachelor’s degree in Engineering, Management, Life Sciences, or another related technical field, or equivalent Nuclear Navy training.
• Five or more years of experience in the pharmaceutical or another regulated industry.
• Depending on assignment, working knowledge of thermal mapping equipment, computer systems and software, or the principles of a specific scientific or technical discipline.
• Proficiency with Microsoft Word and Excel.

Skills

• Proven client relations