The position provides technical support to Delivery Science operations and participates in the technical aspects of process development, engineering development and manufacturing of both GMP and non-GMP customer orders. The position also supports internal technology initiatives and is responsible for supporting the development of project plans and the completion of assigned project deliverables.
Essential Duties & Responsibilities
· Direct engineering responsibilities for product/process transfer from development into manufacturing, verifications/validations & GMP manufacturing operations
· Successfully completes engineering work in support of technology development, product design and process development in preparation for transfer into production
· Collaborates in materials testing, preparation of specifications, preparation and execution of process development studies to facilitate transfer into production
· Supports project planning and administration through all development, testing, and product launch
· Collaborates in defining project scope, developing project plans & schedules, and providing input for project resource planning (equipment and personnel)
· Identifies possible sources of project risk and contributes to the development of risk management, contingency plans and change of project scope as required
· Participate in project meetings with customers as required
· Generate batch production records in support of development and manufacturing campaigns
· Write and/or review verification and validation protocols & reports, GMP batch records, standard operating procedures and work instructions as required
· Supports execution of developmental campaigns for customers and generates reports as required
· Generate and/or support NCRs and CAPAs in collaboration with Quality Assurance to ensure compliance with regulatory requirements
· Assist in the generation & review of new and existing project proposals/quotes.
· Perform procurement activities as required
No direct supervisory responsibilities
· Knowledge and experience of U.S. FDA Regulation 21 CFR Part 210, 211 and 820, ISO 9001:2015 and ISO 13485:2016
· Expertise in polymer hot melt extrusion processing
· Experience in formal Project Management practices in matrix based organizations
· Experience in polymer formulations or compounding a plus
· Experience in drug/device combination products a plus
Education and/or Experience
· B.S. level in Engineering or Science and a minimum of 3 to 5 years’ work experience in a related field or M.S. level in Engineering or Science and a minimum of 1 to 3 years’ work experience in a related field.
· One to 2 years’ experience in contract based R&D (CRO) and/or contract based manufacturing (CMO) is advantageous
Understanding of complex mathematical analysis, calculus, and other mathematics for design and troubleshooting
Ability to solve practical problems an deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
Certificates, Licenses, Registrations
PMP® certification a plus
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to walk, talk, and hear. The employee is frequently required to stand for extended periods of time and to use hands to finger, handle and feel. The employee is required to sit and to occasionally spend long periods of time viewing a computer screen; reach with hands and arms; climb and balance; and stoop, kneel, crouch, or crawl. Specific vision abilities required by this job include close vision, color vision and depth perception.
The work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, and risk of electrical shock. The noise level in the work environment is usually loud. Hearing protection to be used at employee’s discretion.