Position Summary
The Process Engineer serves as a key link between the Innovation Engineering Quality and Operations teams. This role is responsible for driving process optimization technical transfer and validation activities to ensure consistent product quality and operational efficiency. The position requires strong attention to detail effective cross-functional collaboration and a commitment to continuous improvement within a fast-paced production environment.
Key Responsibilities
-
Provide daily technical and quality support to production participating
in daily meetings and resolving plant-level issues. - Ensure quality systems and documentation align with current and upcoming manufacturing requirements.
- Conduct technical reviews of process formulation and packaging changes to safeguard product integrity.
-
Act as a key contributor to the Management of Change (MOC) process.
- Collaborate with cross-functional teams including Operations
- Technology Procurement and external vendors to achieve quality and production targets.
- Support process validation cleaning and sanitization (C&S) validation and development of validation master plans.
- Lead product inspections production line trials and key performance indicator (KPI) monitoring.
- Prepare and execute validation protocols (IQ/OQ/PQ) in coordination with engineering.
-
Conduct GMP and quality training sessions for site personnel.
- Apply quality and continuous improvement tools including CAPA change control deviation investigations and statistical process control (SPC)
- Lead site-level technology transfer and ensure compliance with all validation and documentation standards.
Qualifications
Required:
Preferred:
- Experience with quality systems validation protocols and cGMP standards (21 CFR 210 & 211).
- Familiarity with SAP validation software (e.g. KNEAT) and InBatch or other process control systems.
- Background in a regulated or consumer product manufacturing environment.
Additional Details
Position Summary The Process Engineer serves as a key link between the Innovation Engineering Quality and Operations teams. This role is responsible for driving process optimization technical transfer and validation activities to ensure consistent product quality and operational efficiency. The posi...
Position Summary
The Process Engineer serves as a key link between the Innovation Engineering Quality and Operations teams. This role is responsible for driving process optimization technical transfer and validation activities to ensure consistent product quality and operational efficiency. The position requires strong attention to detail effective cross-functional collaboration and a commitment to continuous improvement within a fast-paced production environment.
Key Responsibilities
-
Provide daily technical and quality support to production participating
in daily meetings and resolving plant-level issues. - Ensure quality systems and documentation align with current and upcoming manufacturing requirements.
- Conduct technical reviews of process formulation and packaging changes to safeguard product integrity.
-
Act as a key contributor to the Management of Change (MOC) process.
- Collaborate with cross-functional teams including Operations
- Technology Procurement and external vendors to achieve quality and production targets.
- Support process validation cleaning and sanitization (C&S) validation and development of validation master plans.
- Lead product inspections production line trials and key performance indicator (KPI) monitoring.
- Prepare and execute validation protocols (IQ/OQ/PQ) in coordination with engineering.
-
Conduct GMP and quality training sessions for site personnel.
- Apply quality and continuous improvement tools including CAPA change control deviation investigations and statistical process control (SPC)
- Lead site-level technology transfer and ensure compliance with all validation and documentation standards.
Qualifications
Required:
Preferred:
- Experience with quality systems validation protocols and cGMP standards (21 CFR 210 & 211).
- Familiarity with SAP validation software (e.g. KNEAT) and InBatch or other process control systems.
- Background in a regulated or consumer product manufacturing environment.
Additional Details
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