About Us:
Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide.
Job Summary:
Responsible for leading and completing engineering investigations, deviations, CAPAs, and change controls while collaborating with Engineering SMEs and cross-functional teams. Acts as a subject matter expert for engineering SOPs, reviews documentation, and assesses impacts on product quality, compliance, and validation. Provides recommendations for process improvements, mentors colleagues, and writes/revises SOPs. Supports production decisions, approves change controls, and ensures compliance with company policies, safety standards, and core values.
Key Responsibilities
- Initiates, reviews and completes Investigations for engineering deviations, investigations, CAPAs, and change controls, working closely with Engineering SMEs.
- Becomes Subject matter expert for engineering relevant SOP’s and forms.
- Reviews and analyzes documents to support completion of the investigation process.
- Serves as an investigation team leader to assess impact on product quality, calibration, facility and utilities compliance and validation status.
- Recommends and monitors improvements in manufacturing and control systems including corrective and preventative actions (CAPA).
- Ability to summarize the results of an Investigation in writing.
- Works together with multiple departments to troubleshoot the production processes and identify process improvement opportunities.
- Provides training and mentoring to colleagues performing investigations.
- Writes/revises SOPs relevant to the Engineering department.
- Working with the Production and Quality teams, assess events when they arise to determine the ability to resume production.
- Performs assessments / approvals of change controls related to production activities.
- Attends meetings to provide updates as well as take away any actions required to be communicated.
- Ensures compliance with all Company policies and procedures including safety rules and regulations.
- Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements
- Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion
- All other relevant duties as assigned.
