Bachelor's Degree in Chemistry, Microbiology, or related field required
5+ years as a Quality Engineer for sterile products
3+ years in product/process investigations and validations
Knowledge of ISO 9001, 13485, and 15378, along with cGMP preferred
Experience in glass forming or pharmaceutical industry preferred
Proficient in MS Office, SAP, and Minitab
Analytical skills with a detail-oriented and service-oriented approach
Responsibilities
Validate and re-validate sterilization processes
Lead regional improvement activities and support rollouts
Trend and monitor quality KPIs for sterile products
Ensure compliance with ISO certifications and cGMP
Support laboratory engineering through validation initiatives
Conduct risk assessments and lead process mapping activities
Analyze quality data, resolve customer issues, and implement CAPA
Benefits
Excellent healthcare benefits including medical, dental, and vision
Short and long term disability
Tuition reimbursement
Paid time off
Pet insurance
Supplemental benefits available upon election
Full Job Description
Your Contribution
Validation and re-validation of sterilization processes
Lead regional or customer led improvement activities and support applicable rollouts
Perform trending and monitoring of relevant quality KPIs pertaining to Sterile products and related quality aspects; implement improvement measures accordingly
Assure compliance with ISO certifications (ISO 9001, ISO 15378) and cGMP, along with adherence to Company policies and procedures and Code of Conduct/safety guidelines
Support the laboratory side of engineering through method and equipment validation/qualification initiatives
Manage and trend data from EM process, raw materials and finished product testing reltated to Sterile products
Perform site based risk assessments
Lead process mapping and continuous improvement activities using Lean principles and tools
Monitor and support the proper implementation of change controls
Support quality control plan analysis and improvements, including packaging development and execution of related projects and action items
Coordinate, collect and analyze quality data for customers; troubleshoot and resolve customer issues; provide root cause analysis and corrective/preventative actions to eliminate reoccurrences
Manage assigned CAPA(s) by performing root cause investigations, while defining resolution actions; implement preventative and corrective actions in a timely manner resulting from customer complaints, internal or customer audit findings
Support experimental and validation protocols for equipment, processes and materials, while designing protocols, performing tests and completing technical reports
Develop and document best practice methods; ensure standardized procedures
Participate in required trainings and meetings, when necessary
Help promote and implement safety/EHS directives and maintain a clean and safe workspace
Your Profile
Bachelor's Degree in Chemistry, Microbiology, or related field, required
Minimum (5) years of experience within a Quality Engineer role with sterile products
Minimum (3) years of experience in product/process investigations, validations, instrument qualifications and EM programs
Solid knowledge of ISO 9001, 13485 and 15378, along with cGMP, preferred
Experience in glass forming industry and/or pharmaceutical industry, preferred
Sound computer knowledge and skills including MS Office, SAP and Minitab
Multi-tasking abilities and prioritization
Detail oriented approach; service oriented
Decision making skills
Forward and creative thinking
Analytical/critical thinking
Effective communication skills
Ability to read, write and speak English language
Your Benefits
Excellent healthcare benefits including medical, dental and vision
Short and long term disability
Tuition reimbursement
Paid time off
Pet insurance
Other supplemental benefits available upon election
