Quality Engineering S [Remote]

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
1223 West Morris Street, Indianapolis, IN - Pharma Services Group

The Quality Engineer is responsible for providing oversight for commissioning and qualification activities at the site, as well as supporting equipment maintenance. In addition, this role supports ongoing quality initiatives and projects in alignment with Thermo Fisher values. Duties also include participating in internal and external audits, conducting FMEA assessments, and driving process improvement. Candidate must be an established quality system leader, strong communicator, and able to work with minimal direct oversight.

Applies Good Manufacturing Principles in all areas of responsibility.
Responsible for ensuring GMP compliance and improving quality systems by leading or participating in projects, policy/procedure revisions.
Review and approve Engineering and Maintenance documents inclusive of engineering studies, FAT/SAT, IQ, 00, and PO.
Provide Quality support in the identification/development/qualification of new processes, featuring/tooling, and technologies into packaging operations.
Support the development of test plans to ensure risk mitigation and quality requirements are met.
Initiate and/or support in the development and/or update of Risk Management FMEA documentation in collaboration with multi-functional engineering teams per project requirements.
Play an integral role in Practical Process Improvement (PPI) program.
Works with FCS sites to assure consistency in validation strategy/approach for local and global projects.
Conduct periodic self-inspections and participate in or internal. client and Regulatory inspections to assure cGMP requirements.
Ensure that the Packaging facility and equipment are maintained in compliance with cGMPs.
Additionally, periodic contact is required with the client in support of the FCS Validation Program, projects, presentations, tours, and capabilities.
Strong attention to detail, collaboration, partnership, influencing, prioritization, decision-making, analytical problem solving, and verbal and written communication skills are required.
Able to travel between sites, including international travel.
Minimum Bachelor's degree in Engineering field
Minimum of 4 years total experience required with equipment/process validation experience.
Equivalent combinations of education, training, and relevant work experience may be considered.
Advanced experience with Microsoft Office Suite {Excel, Word, etc.) Must be a self-starter, have excellent time management and organization skills, a high degree of work quality, attention to detail, and strong communication skills.
ISO 9000/9001, ISO 13485, 21 CFR, and EU MDR especially pertaining to quality management systems, good manufacturing practices, medical devices, and auditing.
Proficiency with the English language.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; Experience with computer system validation is preferred.
Experience with quality system investigations, root cause analysis. and risk assessment tools preferred.

Medical, Dental, & Vision benefits-effective Day 1
Paid Time Off & Designated Paid Holidays
Retirement Savings Plan
Tuition Reimbursement
Relocation assistance is NOT provided