Quality Engineer

Work Schedule

Environmental Conditions

Job Description

Location/Division Specific Information

1223 West Morris Street Indianapolis IN - Pharma Services Group

Discover Impactful Work:

The Quality Engineer is responsible for providing oversight for commissioning and qualification activities at the site as well as supporting equipment 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.

Day in the Life:

• Applies Good Manufacturing Principles in all areas of responsibility.
• Demonstrates and drives the Thermo Fisher values- Integrity Intensity Involvement and Innovation (The Four ls).
• 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.
• Conducts all activities in a safe and efficient manner.
• Able to partner with contacts at all levels of the organization. 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.
• Other duties may be assigned to meet business needs.

Keys to Success:

• Minimum Bachelors 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.) required.
• Ability to work with a variety of functional areas.
• 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.
• Knowledge and experience with external standards: ISO 9000/9001 ISOCFR and EU MDR especially pertaining to quality management systems good manufacturing practices medical devices and auditing.
• Vision requirements for this position: Near Vision Acuity with minimum 20/40 corrected vision (clear vision at 20 inches or fewer) color vision and the ability to adjust focus.
• Proficiency with the English language.
• Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand walk stoop kneel crouch periodically for prolonged periods of time; manipulation (lift carry move) of light to medium weights of 5-25 pounds; arm hand and finger dexterity including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard computer monitor operate equipment and read materials for prolonged periods of time; ability to sit reach with hands and arms talk and hear for prolonged periods of time.

Preferred Qualifications:

• Experience with computer system validation is preferred.
• Experience with quality system investigations root cause analysis. and risk assessment tools preferred.

Excellent Benefits

• Benefits & Total Rewards Thermo Fisher Scientific

• Medical Dental & Vision benefits-effective Day 1

• Paid Time Off & Designated Paid Holidays

• Retirement Savings Plan

• Tuition Reimbursement

OTHER

• Relocation assistance is NOT provided

• Must be legally authorized to work in the United States now and in the future without sponsorship.

• Must be able to pass a comprehensive background check which includes a drug screening