Promega's Validation team needs support in executing scheduled equipment and system qualifications to ensure systems and processes perform as intended and stay in full compliance with quality standards within a regulated biotech manufacturing environment.
Requirements
- Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
- Experience with laboratory equipment and validation software tools.
Responsibilities
- Support the Validation team in executing scheduled equipment and system qualifications.
- Help plan and run qualification activities.
- Coordinate with cross-functional groups to schedule work.
- Maintain accurate documentation throughout each project.
- Investigate and identify performance and process issues, proposing timely recommendations for resolution to management.
- Assist in documentation and logistical tasks related to quality activities, ensuring accurate record-keeping and adherence to protocols.
- Assist in audits by helping to identify and retrieve necessary documents or records in a timely manner.
Other
- Currently pursuing a degree in a science or engineering discipline (e.g., Biology, Chemistry, Biomedical Engineering, Mechanical Engineering, etc.).
- Strong analytical and problem-solving skills with the ability to identify issues and propose effective solutions.
- Excellent organizational skills with attention to detail and accuracy in documentation.
- Effective communication skills, both written and verbal, with the ability to collaborate with cross-functional teams.
- Prior experience or coursework related to quality assurance or regulatory affairs in a manufacturing environment.
- Familiarity with regulatory standards (e.g., FDA, ISO) and their application in a manufacturing setting.
- Ability to remain stationary for extended periods.
- Ability to move and position oneself to access equipment and documents as required.
- Ability to transport items weighing up to 20 pounds between locations.
- Ability to use a computer and related software for long periods.
