Manufacturing Process Engineer
Company: Job Juncture
Location: Saint Paul
Posted on: November 21, 2020
Job Title: Manufacturing Process Engineer, Mechanical
Purpose: Company continues to grow and hiring a second ME to work
In this role you will provide ongoing commercial process support,
improvement, CI initiatives, equipment selection / support and
scientific support to the portfolio of products that are in
commercial and or transitioning into commercial across various
industries. Support the portfolio of products and projects in
accordance with cGMP, FDA, and DEA regulations and standards.
NOTE: This position will start on 1st shift training with advanced
engineers. You will remain on this shift for 6 months to a year
then transition to 2nd shift (working 1pm-9pm, or 2pm-10:30pm, or
6pm-2am), can be flexible on the time.
- Lead Design Reviews and contribute to activities in the
improvement of commercial mix, coat, slitting, converting,
packaging, cartoning and serialization processes for transdermal,
dissolvable films and other drug products.
- Assist and troubleshoot process / equipment issues that occur
during commercial operations and product changeovers. Including
utilization and adjustments of Vision System programs and
- Based on QbD principles, plan and execute process studies for
feasibility, development/characterization (DOEs), capability and
qualification tied to changes on commercialized processes.
- Through CI activities enhance process conditions that increase
quality, yield or reduce set-up and tear-down activities.
- Write specifications, R&D Mfg. instructions, protocols,
SOPs, process development reports, etc.
- Support and follow all regulatory compliance aspects, including
following the necessary change control processes.
- Lead, research and write equipment specifications with support
- Lead / support CI activities that increase efficiencies on
- Support Quality in NCM and CAPA investigations
- Maintain accurate and complete records of development
activities on commercialized processes.
- Support operations with qualification / PM, commercial
manufacturing activities, etc.
- Interface and provide leadership to project teams, vendors and
clients in all activities from re-development to on-going
- Provide technical and/or scientific guidance to operations and
internal teams when appropriate.
- Receive the hand-off of Developed Processes with robust control
processes from Validation and R&D
- Design/re-design tooling, part and packaging equipment for use
in various projects
- Minimum of BS degree in mechanical engineering or related
field, advanced degrees preferred.
- Minimum 10 years of direct industry experience
- Bachelors degree in an engineering or science related field
with a minimum of 3 years of experience or an advanced degree with
0 years of experience.
- Minimum 5 years hands-on experience in manufacturing process
improvement / sustainability within the pharmaceutical industry,
preferably with transdermal and oral dissolvable thin film
products, OR, experience with pressure sensitive adhesive processes
for medical or other applications.
- Ability to review large amounts of data/information, identify
trends, draw conclusions and support a position with text and
- Proven track record of planning and executing process
re-development/ CI projects, and an ability to meet aggressive
- Highly motivated individual who can work both independently and
as part of a cross-functional team.
- Demonstrated problem-solving and analytical skills
- Strong technical writing and oral communication skills. Must be
able to effectively communicate results or issues, verbally and in
- Knowledge and experience with cGMP for pharmaceuticals and QbD
- Knowledgeable and experienced with cGMP, USP and the regulatory
requirements for pharmaceuticals preferred.
- Experience in rotary die cutting and pharmaceutical primary and
- Demonstrated experience drafting 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.
Keywords: Job Juncture, St. Paul , Manufacturing Process Engineer, Engineering , Saint Paul, Minnesota
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