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Fill Finish Engineer
1 month ago
ADVENT Engineering, a Trinity Consultants Company, is a leading engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Our company is headquartered in Dallas, TX, with operations in the Eastern US and Canada, and is involved in various aspects of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.
Our services include process engineering, automation engineering, project engineering, facility/system design, start-up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
Responsibilities:- Supports equipment and new technology design, installation, and qualification.
- Consults on validation and technical transfer activities involving packaging and assembly equipment and processes internally.
- Drafts various SOPs for the assembly and packaging processes and equipment.
- Reviews Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed.
- Interfaces with other departments such as Project Engineering, Validation, DP Process Development, Process Analytical Sciences, Combination Products, Regulatory, Quality Assurance, and Quality Control.
- Recommends capital expenditures and aids in the realization of capital projects.
- Gathers, trends, and analyzes process-generated data.
- Supports onboarding of new materials and vendors.
- Supports management of materials, including coordination with Procurement, Warehouse, Operations, Engineering, and equipment vendors.
- Reviews supplier material change notifications for impact to assembly and packaging processes.
- Supports the creation of training curriculums and content.
- General technical writing support.
Candidates should have 5-10+ years of experience in biotech, pharmaceutical, medical device, or academic or environment. Direct related experience in automated assembly of autoinjectors and/or safety syringe systems and/or automated packaging is a must. We are committed to cultivating an authentic and diverse organization, welcoming all those interested in our work to apply. We are committed to providing an accessible and inclusive interview experience. Please inform us of any accommodations needed to assist you during the interview process.
Applications will be accepted until the role is filled. Only those applicants who are selected for an interview will be contacted. No phone calls please.
