R&D Technician III at PROMED MOLDED PRODUCTS INC – Plymouth, Minnesota
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About This Position
As a ProMed employee, you will contribute to the manufacture of products that have a significant impact on people’s lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best.
ProMed was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world.
Working as one to help many.
POSITION SUMMARYThe mission of this role is to enable the development of manufacturing processes for combination medical devices and complex dosage pharmaceuticals. This position conducts experiments, operates and understands process and testing equipment, and collects data and observations to support process document development. The role supports compliance by following SOPs and cGMP requirements and producing accurate and detailed records of their work. The position follows all safety protocols and supports a culture of continuous improvement.
This position operates under general guidance from R&D engineering staff.
The R&D Technician III ensures ProMed’s brand, philosophy, systems, policies, and procedures are properly implemented and observed.
ESSENTIAL DUTIES & RESPONSIBILITIES
Position duties and responsibilities include, but are not limited to the following:
Execute process experiments, testing procedures, and production activities that generate process data and/or products for testing, ensuring development objectives are met within established timelines and quality standards.
On average this should be about 60% of your time. Among other things this means we expect you to:
- Perform process equipment setup, teardown and cleaning procedures and ensure the systems are ready for development or production activities.
- Conduct process development experiments and document process observations.
- Execute product or process sample characterization testing.
- Identify deviations from expected parameters and report promptly to engineering or QA staff.
- Produce complete and accurate records of development activities in process records and/or laboratory notebooks compliant to GDP requirements.
Maintain laboratory, equipment, and instrumentation in optimal working conditions, ensuring consistent and efficient system performance and a safe working environment.
On average this should be about 20% of your time. Among other things this means we expect you to:
- Perform routine cleaning and maintenance as required per equipment/instrument SOPs
- Support well-organized laboratory and production areas including supply stocking, organization, and waste disposal.
- Support hazard assessments for new chemical reagents and processes before laboratory introduction.
- Monitor compliant use of engineering controls and personal protective equipment during high-risk procedures.
Document experimental results and production activities with precision and completeness, creating reliable records that support product and process quality.
On average this should be about 15% of your time. Among other things this means we expect you to:
- Complete GMP record entries for activities performed (e.g., equipment and cleanroom logs, test records, batch records, etc.).
- Complete laboratory notebook entries in real time during experimental procedures. Ensure all entries are made to ALCOA-PLUS and GDP requirements.
Support a high-functioning technical process development team:
On average this should be about 5% of your time. Among other things this means we expect you to:
- Establishes and cultivates a network of support (quality, operations, engineering, sales, and management) to facilitate completion of assignments.
- Develop acceptable work habits, skills, knowledge, and contributions consistent with the Engineering Technician position level.
- Train and mentor junior staff within the department.
This job also requires performing other duties as assigned.
QUALIFICATION, EDUCATION, & EXPERIENCETo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required:
- Associate’s Degree + 5 years of experience in a technical field -OR- 7 years of experience in a regulated technical environment
- Experience operating processing and manufacturing equipment
Preferred:
- Experience with hands-on technical work
- Experience with characterization tools such as microscopes and measurement tools
- Experience with equipment maintenance and calibration[NL1] [HM2]
- Experience in the medical device and/or pharmaceutical industry
- Experience with extrusion, injection molding, or wet chemistry.
- Chemical production experience
- Experience with MS Office
- Problem-solving and critical thinking skills
- Strong interpersonal, written, and verbal communication skills
- Clearly conveys ideas and receives information effectively
- Self-starter with a proven ability to successfully work with minimal supervision
- Professional, courteous, and friendly personality
- Working knowledge of English (verbal and written)
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the principal roles and responsibilities of this job.
- Duties are performed indoors.
- Exposure to heated/air conditioned, ventilated facilities with florescent lighting;
- Exposure to building where a variety of chemical substances are used for cleaning, and/or operation of equipment;
- Exposure to production areas, including pharmaceutical cleanrooms, where pharmaceutical ingredients are used.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
PHYSICAL, SENSORY, COGNITIVE & NEUROLOGICAL DEMANDS
While performing the duties of this job the employee will require the following capabilities:
- Ability to stand and walk for extended periods (up to 8 hours per day) while working in laboratory and cleanroom environments, with or without reasonable accommodation
- Capability to bend, stoop, kneel, and reach frequently throughout the shift to access equipment, supplies, and work surfaces at various heights, with or without reasonable accommodation
- Ability to lift and carry laboratory equipment, supplies, and materials weighing up to 25 pounds regularly throughout the day, with or without reasonable accommodation
- Ability to work in controlled cleanroom environments while wearing required personal protective equipment for extended periods, with or without reasonable accommodation
- Capability to perform repetitive cleaning and maintenance tasks of laboratory equipment and work surfaces throughout the shift, with or without reasonable accommodation
- Ability to focus visually on detailed laboratory work, measurements, and data collection for extended periods, with or without reasonable accommodation
ProMed offers a generous benefits package including:
- 401k with company match
- Profit Sharing program
- Medical Insurance
- Health Savings Account/Flexible Spending Account
- Dental Insurance
- Vision Insurance
- Life Insurance
- Paid FMLA, and Long-Term Disability Insurance
- Hospital Indemnity, Critical Illness, Accident, and Identity Theft Protection
- Pet Insurance
ProMed does not discriminate in employment opportunities or practices on the basis of race, color, creed, religion, national origin, ancestry, age, sex, marital status, order of protection, disability, military status, sexual orientation, gender identity, pregnancy, public assistance, family status, unfavorable discharge from military service, genetic information or other segmenting factor protected by law, or local human rights commission activity.