Sr. Quality Engineer
Aldevron is an industry pioneer with a core competency in manufacturing for gene and cell therapy. We supply high-quality plasmid DNA, mRNA and proteins to our clients, who are breaking new ground on the world’s most important and challenging solutions to benefit us all. We're looking for innovative, forward-thinking individuals who share our goals of advancing science and making an impact on the world.
Aldevron is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
The Senior Quality Engineer interfaces with Senior members of Quality Assurance (QA), Quality Control (QC), Operations, and Facilities management teams to review manufacturing and Quality Control documentation, disposition materials, and provide real-time operational oversight. This role performs timely reviews of all batch documentation; assure that batch records are complete, correct, accurate, and satisfy all current Good Manufacturing Practices (cGMP) and all current Good Documentation Practices (cGDP) expectations. The role interfaces with technical operations to develop an understating of the critical process parameters associated with manufacturing deviations that can impact product Quality, Safety Purity, or Effectiveness. The role will provide technical Quality oversight to manufacturing Quality Events investigations. The Senior Quality Engineer will perform evaluations of proposed changes to the manufacturing process, materials, components, or records to determine the effect on the manufactured product.
Responsibilities:
- Cross functional support including gap analysis, FMEA, risk assessments, root cause analysis, tracking and trending, statistical modelling (linear regression, T-test, control charts, etc.), and develop/maintain client specific process datasets.
- Perform GMP oversight, and “real time” review of manufacturing documentation including batch records and protocols during execution.
- Release manufacturing rooms following required reviews and after confirming acceptance criteria have been met.
- Assist in developing process capability metrics and other statistical tools to evaluate ongoing process performance.
- Able to assess and review SOPs and forms to determine compliance to a standard.
- Responsible for timely completion of review and/or investigation into Corrective Action Preventive Actions and other Quality Investigations.
- Perform timely and thorough review of all batch documentation to assure that all documentation is complete, accurate, and that it conforms to all regulatory and statutory requirements for release.
- Develop knowledge on critical process parameters in the manufacturing process.
- Provide Quality oversight to Quality Event investigations.
- Provide guidance and leadership in absence of Manager
- Perform assessment of proposed changes to the manufacturing process, materials, components, or records to determine the effect on the manufactured product.
- Review and approve new manufacturing batch records.
- Review and approve new processing equipment .
Qualifications:
- Bachelor of Science, life science related, preferred. Equivalent experience may be considered
- A minimum of five (5) to seven (7) years of experience in a Quality or auditing role. If experience is in an equivalent GMP facility, such as biotech, pharma, medical device manufacturing, etc.,
- Experience working in a regulated or GMP compliant environment
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.