Top 7 Senior validation engineer Jobs in Alachua, Fl

Sr. Quality Engineer
Evergen —Alachua, FL
- $90,000 - $115,000 a year
- Full-time
- Office
- Bachelor's degree
- Senior level
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Senior Software Engineer
TaxPlanIQ —United States
- $100,000 - $140,000 a year
- Email
- Remote
- Background check
- System design
- Java
- Health insurance
- Dental insurance
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Sr. Quality Engineer

Evergen -
Alachua, FL

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Job Details

Full-time
$90,000 - $115,000 a year

Qualifications

Productivity software

Full Job Description

Location: Alachua, FL

Evergen 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 ;

RESPONSIBILITIES

Serves as a lead core team member of cross functional project teams whose responsibilities include coordinating deliverables for the improvement of processes across the manufacturing facility
Supervises the Quality Assurance Engineering team including performance management, corrective action, hiring and selection, and allocation of engineering support as it relates to quality assurance initiatives
Reviews quality Key Performance Indicator (KPI) data and actions to ensure continuous improvement in collaboration with various operations value streams
Reviews validations and risk management activities to support regulatory submissions, sustaining activities, and product launches are on time and have a high level of customer and patient focus
Leads and conducts problem solving through change management, nonconformance workflows, and continuous improvement or new product development initiatives
Reviews and edits nonconformance investigation and disposition phases for team members and assists in the preparation and presentation of materials for quality initiatives
Other duties as assigned

REQUIREMENTS

Education

Bachelor’s degree in relevant technical discipline

Experience

6+ years of relevant medical device, pharmaceutical, or other regulated industry experience.
- Combination of advanced degree and experience may be considered.

Certification

AATB or CTBS Certification, preferred
Lead Auditor Certification, preferred
ASQ – CQE, CBA, or CQA, preferred

Skills

Excellent verbal and written communication
Technical writing
Problem solving methodologies
Microsoft Office Suite
Quality Management System software
Investigations
Statistical techniques

Travel

SAFETY

Physical Requirement

Move or lift objects up to 25 pounds
Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)

Working Environment

Onsite: Office environment with assigned workstation
Remote positions only: Home office environment with minimum distractions

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

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