What are the responsibilities and job description for the Facilities Technician II position at Evergen?
Location:
6455 City W. Pkwy, Ste 100 Eden Prairie, MN
Pay Rate:
- $22-$25 / hour
- $2,500 eligible annual bonus target
- Benefits including health, dental, vision, PTO, & paid holidays
Schedule:
Standard Hours are Monday - Friday, 8am-5pm
RTI Surgical / Collagen Solutions is now Evergen!
This rebrand reflects our strategic evolution as a leading CDMO in regenerative medicine and comes at the end of a significant year for the business, including the successful acquisitions of Cook Biotech in IN. and Collagen Solutions/Midwest Swine, MN. Our new brand identity emphasizes our unique positioning as the only CDMO offering a comprehensive portfolio of allograft and xenograft biomaterials at scale.
About Evergen:
Evergen (formally RTI Surgical) is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ. Read more about this change and Evergen’s commitment to advancing regenerative medicine here: https://lnkd.in/eMSfVJkM
POSITION SUMMARY:
Purpose of this position is to provide support to production operations either directly by assisting with production related activities or indirectly by maintaining and/or introducing new critical building equipment and systems.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
- Perform and/or facilitate equipment calibrations and preventative maintenance in accordance with internal procedures on process and/or test equipment and facility plant systems within specific timescales / deadlines to keep calibration and maintenance schedule up to date.
- Perform plant walk-arounds recording the status of plant equipment and associated systems to aid in preventative maintenance. Data gathering on the performance of equipment.
- Communicate with other departments to assist in the planning of planned or unplanned maintenance which may affect production or quality.
- Assist with the control and monitoring of production related materials and critical spares.
- Liaise with external service providers who visit the site to perform critical works, as required.
- Execute equipment validations, as assigned, on new and existing equipment including IQ/OQ/PQ to ensure that equipment conforms to required specifications. To include introduction of new equipment and systems for production use.
- Writing/editing documentation such as work instructions, SOP’s etc as applicable.
- Assist with waste disposal procedures to ensure the safe and compliant disposal of waste from the site.
- Participate in Health and Safety initiatives throughout the site.
- Ensure all activities are performed in accordance with cGMP where applicable, ISO 13485 / ISO 22442 and any other relevant regulations or SOPs. Always keep training folder up to date.
- Actively support timely closure of CAPAs, Non-conformances, and deviation reports wherever the area of expertise allows
QUALIFICATIONS
- Experience working under an ISO 13485 quality system.
- Calibration and maintenance experience.
- Stock control and management experience preferred.
- Associate or bachelor’s degree preferred.
- Experience within Medical Device Industry preferred.
KNOWLEDGE & SKILLS
- Fault finding and resolution.
- Safe manual handling activities.
- Escalation of identified issues in a timely manner.
- Teamwork, Communication & Continuous Improvement mindset.
- Proficient with Microsoft Office (Word, Excel, Project etc.).
- Strong organizational and time management skills.
- Strong ability to demonstrate sound judgement under all circumstances and in a timely manner.
- Excellent interpersonal and collaborative skills, with a professional demeanor and the ability to interact with all levels of management, colleagues, and vendors.
- Effective oral and written communication.
- Validation of new and existing equipment.
- Detail-oriented.
- Ability to be self-motivated and to work independently.
More about Evergen:
Evergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management.
Evergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values:
- Accountable: We own our actions and decisions.
- Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth.
- Growth Mindset: We embrace challenges as opportunities for continuous learning.
- Customer-Centric: We prioritize customers at every touch point.
- Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated.
At Evergen, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success.
Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential.
#LI-Onsite
Salary : $22 - $25