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Tom's of Maine · 2 days ago

Process Engineer

Sanford, ME

Full-time

Onsite

Entry, Mid Level

$79K/yr - $111K/yr

2+ years exp

Colgate-Palmolive Company is a global consumer products company specializing in various care products. The Process Engineer role is focused on providing critical support to the Innovation team and ensuring product quality through process optimization, validation, and collaboration with key business partners.

Manufacturing

Comp. & Benefits

Responsibilities

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

Qualification

Chemical EngineeringQuality SystemsProcess ValidationSAPProject ManagementGMP KnowledgeCommunication SkillsTeam Collaboration

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