KnowHireMatch ยท 2 months ago
Quality Process Engineer
Sanford, ME
Full-time
Onsite
Mid, Senior Level
$80K/yr - $115K/yr
2+ years expKnowHireMatch is a company focused on optimizing quality processes in manufacturing. The Quality Process Engineer will bridge the gap between technical development and plant operations, ensuring quality compliance and driving continuous improvement in a regulated environment.
Staffing & Recruiting
Responsibilities
Oversee and manage the site validation program, including Cleaning and Sanitization (C&S) validation plan leadership and execution
Conduct risk analysis, maintain and update the Validation Master Plan, and develop Performance Qualification (PQ) protocols, supporting IQ/OQ in partnership with the Engineering team
Ensure compliance with quality standards, including cGMP and 21 CFR 210 & 211
Lead the Technology Transfer Quality Standard application specific to site activities
Manage SAP item setup and ensure accountability for the Management of Change (MOC) process
Lead the creation, optimization, and management of Inbatch recipes
Conduct technical reviews of changes in specifications, processes, formulas, packaging, and labeling to ensure product quality
Ensure site quality systems are configured for current and upcoming production requirements in a timely manner
Provide daily on-the-floor support to address quality issues and continuous improvement initiatives, actively participating in site Standard Daily Meetings (SDM) and Internal Quality Area Meetings
Utilize quality tools such as Change Control, Failure Investigation, Control Charts, Corrective & Preventive Actions (CAPA), and Notice of Deviations to drive continuous improvement
Lead product inspections, line trials, and other Quality Key Performance Indicator (KPI) activities
Interface effectively with key business partners including Operations, Technology, Procurement, and Vendors
Conduct training sessions on topics like GMP, quality standards, and validation
Qualification
Required
Education: Bachelor's degree in Chemical / Mechanical Engineering, Chemistry, or a related science/engineering discipline
Experience: A minimum of 2-3 years of experience in manufacturing, a quality role, or equivalent. (Mid-Senior level experience preferred)
Skills: Demonstrated project management skills and the ability to communicate effectively and deliver results in a fast-paced work environment
Preferred
A strong background in quality systems, process validation, and a thorough understanding of cGMP and 21 CFR 210 & 211
Prior experience working in a regulated industry (e.g., FDA-regulated)
Working knowledge of SAP, validation software (e.g., KNEAT), InBatch, or similar plant/quality-related computer systems
Benefits
Bonus
Full Benefits
Company
KnowHireMatch
In Today's challenging Job Market the advantage always goes to the first mover.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase