Engineer III, QA (2nd Shift)

As 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.

Location / Division Specific Information

This position will work with the Carlsbad, CA site, and will support our Biosciences Division (BID Operations) business unit of Thermo Fisher Scientific.

Schedule : 2nd Shift Role : M-F 11pm - 8pm

Discover Impactful Work :

We are looking for a self-motivated, experienced and resourceful Quality Engineer. This role is responsible for Quality Engineering support of Gels, NGS and other products' manufacturing that are part of Biosciences Division (BID) and Clinical Sciences Division (CSD), within of our Life Sciences Solutions Group (LSG).

LSG is experiencing outstanding growth supporting exciting markets : Academia, Research, Biotech, Pharma, Cell and Gene Therapy and Medical Devices.

A Day in the Life :

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 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

Handle 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

Drive a culture of continuous improvement by employing Practical Process Improvement concepts.

Support complex, multi-functional quality issues in a variety of subject matter areas ( 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.

Keys to Success : Education

Education

Bachelor’s degree in Science required. Preferably in Engineering, Biochemistry, Biotechnology, Biology or Biomedical Engineering.

Experience

At least 3 years’ experience within a highly regulated field. Preferably in Medical Device or Pharmaceutical Industry supporting Regulated Products.

Experience in GMP guidance, including 21 CFR Part 11 required.

Prefer hands-on industry experience in cGMP / Biotech / Biopharmaceutical / FDA regulated industries.

Knowledge, Skills, Abilities

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.

Knowledge of quality standards (, 21 CFR Part 820, ISO 9001 / 13485, MDSAP, excipient manufacturing regulations) and Quality Management System design and oversight from a Medical Device or Pharmaceutical perspective.

Quality tools FMEA, Risk Analysis, Root Cause Analysis

Global Systems TrackWise, OCPLM, E1, LIMS

Proficient in Computer applications and software (Microsoft Excel, Outlook, Word, Access, Project); compliance specific software programs (OCPLM, 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

Compensation and Benefits

The salary range estimated for this position based in California is $83, - $125,

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 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) retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
30+ days ago