ADVENT Engineering, a Trinity Consultants Company, is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered in Dallas, TX with operations in the Eastern US and Canada, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.
ADVENT's 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.
Requirements:
Preferably with manufacturing start-up/qualification experience.
Automated assembly of autoinjectors
Automated assembly of safety syringe systems and automated packaging.
Responsibilities:
Supports equipment / new technology design, install and qualification.
Consults on validation and technical transfer activities involving packaging and assembly equipment and processes internally.
Drafting 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.
Review supplier material change notifications for impact to assembly and packaging processes
Supports the creation of training curriculums and content
General technical writing support
5-10+ years of experience in biotech, pharmaceutical, medical device, or academic or environment.
Candidates, please note: Kindly ONLY apply if you meet the experience expectations described: Competencies in the automated assembly of autoinjectors and/or safety syringe systems and/or automated packaging is a MUST. Candidates with direct related experience interested in US locations are encouraged to apply.
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.