Niowave, Inc. · 2 weeks ago
Principal Validation Engineer
Lansing, MI
Full-time
Onsite
Lead/Staff
15+ years expNiowave, Inc. is a team of scientists and engineers dedicated to developing medical isotopes for cancer treatment. The Principal Validation Engineer will lead the validation program, ensuring compliance and operational excellence while fostering a culture of safety and continuous improvement.
ManufacturingPharmaceutical
Responsibilities
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
Qualification
Required
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
Preferred
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
Company
Niowave, Inc.
Niowave is advancing cancer treatment by producing Actinium-225 (Ac-225) with cutting edge linear accelerator technology and radiochemistry.
51-200 employees
H1B Sponsorship
Niowave, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (2)
2022 (1)
2021 (1)
Funding
Current Stage
Growth StageTotal Funding
$5.2MKey Investors
Michigan Economic Development Corporation
2023-04-11Grant· $0.5M
2021-12-14Series Unknown· $1.7M
2019-08-20Series Unknown· $3M
Leadership Team
Terry Grimm
Chief Executive Officer
Recent News
2025-12-20
2023-04-13
Company data provided by crunchbase