Job Description2nd Shift Role: M-F 12pm - 8pmAs part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer! We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.How will you make an impact?We are looking for a self-motivated, experienced and resourceful Quality Engineer with up-to-date knowledge, and demonstrated experience driving and sustaining improvements to the Quality Management System to ensure compliance to all applicable standards.When you join us at Thermo Fisher Scientific, you’ll be part of a hard-working, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.This role is responsible for Quality Engineering support of a recently built enzyme manufacturing facility serving pharmaceutical customers. This operation is part of our Biosciences Division (BID), within of our Life Sciences Solutions Group (LSG). BID is experiencing outstanding growth supporting exciting markets: Academia, Research, Biotech, Pharma, Cell and Gene Therapy and Medical Devices.What will you do?
Collaborate across functions and sites, applying quality and manufacturing expertise to solve problems, interpret data and determine next steps based on risk-based approach.
Manage problem requests (nonconformances), complaint records, and corrective and preventive actions (CAPAs)
Support in global change control activities for documents and manufacturing processes
Assist with regulatory, customer and internal audits
Provide guidance and direction to ensure ISO/Quality system compliance
Manage maintenance, completeness and accuracy of Quality records
Perform training on Quality procedures/processes
Create, review and review quality processes and procedures
Collect, analyze, trend and report out on quality metrics
Driving a culture of continuous improvement by employing Practical Process Improvement concepts.
Supports complex, cross-functional quality issues in a variety of subject matter areas (e.g. biology, electrical, mechanical, chemistry and software) and drives resolution and proactive solutions to customer complaints (functional defects with components or performance related failures), backorder issues, and material disposition.
Provide knowledge and guidance on validation and stability testing activities.
Perform other duties, as assigned.
How will you get here?Education
Bachelor’s degree from an accredited college/university with a preference for Science, Engineering, Biochemistry, Biotechnology, Biology or Biomedical Engineering.
Experience
Minimum of 3-5 years’ experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products.
Solid understanding of GMP guidance, including 21 CFR Part 11.
Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.
Knowledge, Skills, Abilities (Required)
Excellent communication, collaboration and interpersonal skills with the ability to facilitate team interactions, partner with and influence key stakeholders.
Work with diverse teams, guide teams through decision making, facilitate agreement, build collaborative relationships and focus on customer needs.
Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency.
Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts.
Expert knowledge of quality standards (e.g., 21 CFR Part 820, ISO 13485, MDSAP, excipient manufacturing regulations) and Quality Management System design and oversight from a Medical Device or Pharmaceutical perspective.
Compliance with regulated quality management system standards
Quality tools e.g. FMEA, Risk Analysis, Root Cause Analysis
Global Systems e.g. TrackWise, AGILE, E1, LIMS
Proficient in Computer applications and software (Microsoft Excel, Outlook, Word, Access, Project); compliance specific software programs (Agile, Trackwise, LIMS, Master Control, ERP, etc.).
Knowledge, Skills, Abilities (Preferred)
Experience with biological manufacturing processes.
Project Management advanced experience.
Certified Lean Professional or Six Sigma
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Accessibility/Disability AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.Compensation and BenefitsThe salary range estimated for this position based in California is $83,300.00 - $125,000.00.This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewardsCompensation and BenefitsThe salary range estimated for this position based in California is $84,000.00–$125,000.00.This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewardsThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
