Process Engineer

Job Description

Job Description

Thompson First Group is currently seeking a qualified Process Engineer for a local client in Sanford, Maine.

Candidates that have a background in process optimization and validation and have an educational background in Chemical or Mechanical engineering are encouraged to apply.

Description

The Process Engineer provides a critical link between the Innovation team including Implementation and Support (I&S), Engineering (PD&I), Category Technical Managers, Plant Operations, and Quality. The role requires attention to detail while working at an energetic pace. The Quality Engineer is active and visible in promoting plant quality performance and consumer satisfaction supported with a strong and effective internal / external networking. Key technical deliverables include; process optimization and validation, technical transfer including SAP item setup and Management of Change accountability, Cleaning and Sanitization validation plan leadership and execution for the site, and Inbatch recipe creation, optimization and management.

Responsibilities include :

Provide daily support to the plant to address quality issues and continuous improvement initiatives by spending time in the production area and participating in the site Standard Daily Meeting (SDM) and Internal Quality Area Meetings.

Ensure site quality systems are configured for current and upcoming production requirements in a timely manner.

Conduct technical reviews of changes in specifications, processes, formulas, packaging, and labeling, to ensure product quality. Key contributor to the Management of Change process.

Interface effectively with key business partners including Operations, Technology, Business Unit, Procurement,and Vendors to drive Company results.

Support key activities at the site by : reviewing processes and procedures including validation protocols, lead pre and post launch review meetings, submit stability samples for testing, external audit participation and other tasks as needed.

Process Validation & Control : Oversees the validation program, including C&S, conducts risk analysis, maintains and updates, validation master plan, develops validation protocols for PQ, supports IQ / OQ in conjunction with the engineering team.

Lead product inspections, line trials and other Quality Key Performance Indicator (KPI's).

Conduct training sessions on topics such as GMP, quality standards, validation, etc.

Utilize quality tools such as Change Control, Failure Investigation, Control Charts, Corrective & Preventive Actions (CAPA) and Notice of Deviations, etc. to help drive continuous improvement.

Lead the Technology Transfer Quality Standard applicable to the Site for those specific site-related activities.

Qualifications

Required :

Bachelor's degree in Chemical / Mechanical Engineering, Chemistry or related science / engineering discipline.

A minimum of 2-3 years of experience in manufacturing, a quality role or equivalent.

Demonstrated project management skills, ability to communicate effectively and deliver results in a fast paced work environment.

Preferred :

A strong background in quality systems, validation, understanding of cGMP and 21 CFR 210 & 211, and experience in working in a regulated industry (i.e. FDA)

Working knowledge of SAP, validation software (KNEAT), InBatch or similar plant / quality related computer systems.

Thompson First Group is an equal opportunity employer. All applicants will be considered for employment regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and / or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.