R&D Process Engineer

Industry

Engineering

Advert ID

FOX_BBBH13434

Location

West Saint Paul

Job Type

Permanent

Hours

Full-Time

Salary Range

USD70000-105000 per year

No. of Openings

1

Branch Information

Manpower Engineering ,

ContactNumber

Job Description

Sr. R&D Process Engineer | Direct Hire | $70-$105k | Pharmaceutical/Med Device Industry



Provide ongoing scale up, process development, and scientific support to the portfolio of TM products, client projects and upcoming projects across various industries. Product types will include (but are not limited to) supplements, pharmaceutical, environmental, medical device, and nutraceutical. Scale up activities will be tailored towards transdermal, oral thin films, and topical products.



Principal Responsibilities:





* Lead Design Reviews and contribute to activities in the development of commercial slitting, converting, packaging, cartoning and serialization processes for transdermal, dissolvable films and other drug products.

* Based on QbD principles, plan and execute process studies for feasibility, development/characterization (DOEs), capability and qualification.

* Establish optimum process conditions for product quality, throughput and yield.

* Write specifications, R&D Mfg. instructions, protocols, SOPs, process development reports, etc.

* Follow Tapemark's applicable policies and procedures throughout all development activities

* Support Manufacturing Engineers with equipment specifications

* Support Validation group with IQ, OQ and PQ

* Lead FMEA and Risk Assessments with support of Validation and Quality

* Maintain accurate and complete records of development activities

* Support operations with qualification / PM, commercial manufacturing activities, etc.

* Interface and provide technical leadership to project teams, vendors and clients in all activities from development to validation scale production.

* Provide technical and/or scientific guidance to operations and internal teams when appropriate.

* Support the hand-off of Developed Processes with robust control processes to Validation and Manufacturing

* Design/re-design tooling, part and packaging equipment for use in various projects

* Other duties as assigned



Job Qualifications:





* BS: Biomedical, Mechanical or Manufacturing Engineering degree ONLY!

Hands on person | okay being on the floor

5+ years as a Process Engineer in GMP setting (Pharma, med device or food industry)



* Knowledgeable and experienced with cGMP, cGLP, USP and the regulatory requirements for pharmaceuticals preferred.

* Demonstrated experience drafting R&D Manufacturing Records, SOPs, master plans and additional protocols

* Proven scientific and technical ability to design and execute experimental studies as well as statistically analyze data, author and review protocols and reports.