In this position you will provide primary product and process technical support to improve current ACC products and processes. In addition, there will be a significant role providing support for new product development projects, and quality system events.
- Will provide primary technical support for existing product manufacturing with emphasis on yield monitoring, failure analysis, and process improvements for all ACC products.
- Support ACC projects with all required updating of Bills of Materials (BOMs) and routers in Great Plains inventory system as would be expected from an Engineering function to ensure accurate BOMs and routers are in the system.
- Develop project cost estimates for ACC new/ improved product projects, working with project team, finance and management to provide accurate estimates.
- Support current manufacturing of ACC products by performing investigations relating to quality events, deviations, audits, CAPAs, & complaints as well as complete assigned action items as appropriate.
- Create and revise procedures/ forms as required in the electronic document management system to assure accurate description of processes and to document changes.
- Train personnel to procedures and protocols.
- Provide Engineering support on teams for product transfer and new product development projects.
- Support to validation activities as required.
- Other tasks as assigned in alignment with corporate priorities and objectives.
KNOWLEDGE AND SKILL REQUIREMENTS:
- Excellent technical written and oral communication skills. Demonstrated critical thinking and problem solving skills. Skills in presenting data clearly.
- Demonstrated experience in leading teams, contributing technical support in a team setting, and strong troubleshooting skills. Attention to detail and excellent organizational skills is essential.
- Ability to work both independently and in a cross-functional team environment.
- Experience working in a regulated environment. In-depth knowledge of FDA cGMP and/or ISO regulatory requirements a plus.
- Demonstrated experience in creating validation or technical study protocols and reports.
- Experience with an electronic document management system required.
- Design control and project management skills desired.
- A demonstrated ability to work effectively with suppliers/ contractors/ customers is desired.
EDUCATION AND EXPERIENCE:
The Ideal candidate will have a minimum of a Bachelor’s Degree in a Science or Engineering discipline or an equivalent combination of experience and/or education.
At least 8 years of experience in the medical device, pharmaceutical, clean room, or biotech manufacturing industry
Knowledge of pharmaceutical/ biopharmaceutical, or related production processes required, familiarity with ACC processes and testing preferred.
Experience in running assays with ACC reagents and instruments preferred.
Job Type: Full-time
- Relevant: 1 year (Preferred)