Principal Validation Engineer
Who we are…
We are a team of scientists, engineers, technicians, and innovators dedicated to changing the world by developing medical isotopes to treat and eradicate cancer.
We believe in building an environment where collaboration, curiosity, and camaraderie thrive.
We also enjoy darts, cornhole, ping-pong, chili cook-offs, and other fun events that make our company a community where we make a life, not just a living.
Who you are…
You have a precise nature and embrace attention to detail. You value established procedures to ensure first-time quality for accurate and on-time results. Words that describe you are consistent, efficient, diligent, technologically savvy, and having a continuous improvement mindset. You embrace change to keep pace with emerging information and shifting priorities, offering suggestions to improve process flows. You get great satisfaction from launching new products, improving compliance with existing products or procedures. You easily transition between working independently to working with a team with excellent customer service as your internal guide.
How you will have an impact…
- The Principal Validation Engineer role encompasses leadership, subject matter expertise, operational excellence, and fosters a culture of safety, quality, continuous improvement, and the ideal staff member experience.
- The Principal Validation Engineer provides direct management of the equipment, facility, and utility validation program. This role builds phase appropriate and commercial systems for API cGMP compliance to meet the expanding needs of the radioisotopes business. This position also serves as a key member of expansion projects (such as new production facilities).
- The Principal Validation Engineer drives results through collaborative project management methodologies, strong technical review, and decision-making processes, role modeling the desired behaviors, and leading risk-based methodologies to build quality into our product by design.
What you need to succeed…
- Bachelor degree in Science, Technology, Engineering, Mathematics (STEM) field or related field.
- 15+ years progressive subject matter expertise positions within validation activities in a highly regulated environment.
- 10+ years’ experience with the following:
- Drug or API pharmaceutical facility design experience and understanding of requirements.
- Validation techniques, including analytical equipment, facility and utility qualification, with an emphasis on risk assessment methodologies.
- Product lifecycle management (PLM) and manufacturing execution systems (MES).
- cGMP regulations (US and EMA); cGMP regulations, risk-based approaches, and Quality by Design (QbD) principles in the context of pharmaceutical development
- Commissioning and Qualification of process equipment, architectural design and utility systems.
- Supporting audits (FDA, ISO, internal) as a validation SME.
- 8+ years’ experience providing successful teaching, mentoring, and skill development for staff directly or indirectly assigned to validation/quality activities.
- 3+ years of knowledge and application of Lean Manufacturing/TPM/Six Sigma methodologies.
- Embraces and models the Niowave Values of Teamwork, Courage, Integrity, and Upright Zeal.
- Understands how to integrate into a new team/organization – appreciates the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state.
- Understands your own communication and learning styles, can assess others’ styles, and is able to find the right path to connect the two.
- Analytical and problem-solving skills; excellent interpersonal, written, and oral communication skills; Organizational and project management skills for self and teams.
Great to have…
- Masters degree in Science, Technology, Engineering, Mathematics (STEM) field or other related field.
- 20+ years progressive subject matter expertise positions
- Experience with Accelerator and Radiopharmaceutical systems
- ASQ Certifications
- Lean/Six Sigma Certifications.
- Project Management Certifications (PMP, CSM, PSM, SAFe, etc.)
- Knowledge of NRC regulations.
- Involvement with ISPE, PDA, BPOG or other industry groups
Work Environment
- The company’s standard operating hours are Monday thru Friday 6a – 6p with production related activities requiring 24/7/365 shifts.
- This position will have regular working hours during M – F with an expectation of adjusting to work outside of the standard operating hours as needed.
- Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role.
