What are the responsibilities and job description for the Senior Process Engineer position at Harba Solutions Inc.?
Responsibilities
- Provide support for cross-functional projects and teams by evaluating, designing, and implementing robust processes for new products using existing or new manufacturing equipment.
- Create technical documentation, including protocols and reports for equipment/instrument qualifications, comparability studies, and process validation/testing in manufacturing environments.
- Actively participate in product launch activities (preferred).
- Collaborate with teams to efficiently transition projects from initial scoping to successful implementation.
- Offer expertise in Aseptic Manufacturing and contribute to the evaluation and design of new processes.
- Partner with the Quality team to ensure the implementation of high-quality standards and adherence to cGMP practices during new product launches.
- Contribute to the forecasting of project-related costs and assist with tracking project tasks to ensure milestones are met.
- Ensure compliance with US and international regulatory requirements and guidelines (e.g., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP).
Qualifications
- Bachelor’s degree in a related field such as Bioengineering, Chemistry, or Biotechnology.
- A minimum of five years of relevant experience working in cGMP manufacturing environments, with a strong background in process optimization and establishing process KPIs.
- Experience in the pharmaceutical industry is desired, though candidates with experience in other development fields (e.g., medical devices) will also be considered.
- Lean and/or Six Sigma certification is preferred.
Salary : $105,000 - $120,000
