Senior Manufacturing Engineer at Pelican Products in Plymouth, Minnesota

Job Description:

We Build Careers As Strong As Our Products

Pelican BioThermal LLC is a global leader in the design and manufacture of single use and reusable temperature controlled packaging solutions for the highly regulated pharmaceutical, biotech, and clinical trials industries. Pelican BioThermal is a great place to work and offers employees the opportunity to flourish and excel in a high-growth, fast-paced, creative, and exciting environment! We currently have an opening for a Senior Manufacturing Engineer based at our site in Plymouth/Maple Grove, MN.

The Senior Manufacturing Engineer is responsible for taking a proactive approach to specification, installation and validation of all manufacturing and assembly equipment, support the on-going maintenance of on-site equipment, process development and improvements, and to establish continuous improvement activities for the development of manufacturing processes.

What You'll Do:

• Responsible for manufacturing equipment inclusive of machines, tools, jigs and fixtures.


• Responsible for the implementation of manufacturing processes for existing and new products.


• Develops tools to support process throughput, including time studies, line balancing, staffing, and capacity.


• Prepares and executes validation activities on site, at supplier premises and at third party manufacturing facilities as needed.


• Responsible for development and support of the Preventive Maintenance Program including improvements where needed.


• Reviews design proposals and specifications ensuring manufacturability, defining equipment requirements and estimates build costs by providing process expertise and technical support for manufacturing equipment.


• Executes CGMP process documentation guidelines.


• Develops and manages manufacturing specifications, work instructions, CAD technical drawings and SOPs.


• Interfaces with all levels and areas of the business to achieve department goals including quality, maintenance, purchasing, shipping, and production.


• Train production staff on proper equipment operating techniques and best practices.


• Plans and executes approved projects for both existing and emerging technology, to agreed specifications and targets (cost, time, and performance) and provides technical support to operators, covering all manufacturing and assembly issues.


• Ensures production processes are capable and robust using tools such as PFMEA.


• Prepares and executes validation plans for IQ, OQ, and PQ.


• Identifies areas of continuous improvement in production processes and techniques to support cost improvement initiatives.


• Leads, communicates, and manages engineering projects.


• Ensures safety, statutory, and regulatory requirements are met.


• Evaluates and selects equipment suppliers against specifications and manages suppliers to project completion.


• Communicates project status updates to the project manager, sponsor and customer as required.


• Accountable for all equipment documentation from specification and validation to production handover, ensuring all relevant requirements are met. Ensures training and handover procedures are completed and documented.


• Provides process expertise and technical support for manufacturing equipment and processes employed.


• Follows company policies and practices as outlined in Handbook and follow guidelines regarding safety as outline in the AWAIR, and other safety procedures in accordance to the job.


• Performs additional duties as assigned.

What You'll Need:

• Degree in Engineering or equivalent recognized engineering qualifications with 5-8+ years of related experience in an Engineering role.


• Experience in the following: Food/Medical Device/Pharma packaging which includes sealing equipment, automation and robotics equipment and technologies, and conveyorized and robotic manufacturing equipment.


• Knowledge and experience with the following: Project Management, Design of Experiments (DOE), Statistical Data Analysis Software, Design for six sigma and continuous improvement methods, risk analysis methods/DFMEA, and verification and validation methods.


• Must have experience with equipment specification and installation projects.


• Excellent teamwork and teambuilding skills with a "can-do" attitude.


• Must have excellent written, verbal communication and presentation skills.


• Must be able to identify and resolve problems in a timely with the ability to use sound, evidence-based approaches to problem solving and quality enhancement.


• Ability to travel for supplier visits and to validate equipment nationally and internationally, as necessary.

Preferred Qualifications:

• Pharmaceutical or Medical Device industry experience.


• Solidworks CAD, Ladder Logic programming for PLCs experience.


• Knowledge and experience working with ERP systems.

Additional Information:

• Actively supports and complies with Pelican's objectives, guidelines and commitment to Quality and Safety, with an emphasis on continual improvement.


• Must be able to interact effectively and cooperatively with employees at all levels.


• Must have the ability to complete assignments within the timeframe specified by the Manager.


• Must be able to operate in a fast-paced environment and handle multiple projects simultaneously.


• Must be flexible regarding working hours as needed to be successful in the position.


• Emphasizes ethical leadership and decision-making to protect Pelican's brand and reputation.

Why Join Pelican BioThermal? Here's a glimpse of Pelican Perks...

• Generous paid time off plans.


• 401k plan - with a competitive match.


• Tuition Assistance Program.


• Established reputable brand offering premium products - you'll be proud to represent Pelican!


• Employee discount program on Pelican Products.


• Great Benefits - several options including Pet insurance for our animal lovers.


• Wellness Discount Program.


• Lucrative employee referral program - get paid to work with your trusted network.


• And more...

PHYSICAL REQUIREMENTS AND WORKING CONDITIONS

• While performing the duties of this job, the employee will be frequently required to execute standard physical activities within the facility areas (i.e. stand, walk, sit, use hands/fingers).


• While performing the duties of this job, the employee will be occasionally required to execute non-standard physical activities within the facility areas (i.e. climb or balance, stoop, kneel, crouch).


• Ability to lift and/or move up to 20 pounds and occasionally lift and/or move up to 40 pounds.


• This position requires repetitive hand/wrist activities.

#LI-POST

#PELICANBIOTHERMAL

Pelican Products, Inc. is an Equal Employment Opportunity/Affirmative Action employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.