Process Engineer

at  Katalyst Healthcares Life Sciences

Responsibilities :

• The engineer/scientist in manufacturing Support operations is responsible for execution of the manufacturing process in a multi-product cGMP facility capable of manufacturing commercial, clinical and development drug substance.
• Additional roles include using operational and technical knowledge to lead, oversee, and evaluate troubleshooting activities, tech transfer and start-up activities, investigations, analyse/interpret process data, and identify and implement complex process improvements.
• Contribute to the completion of projects and manage own time to meet agreed targets.
• Understand the fundamental business drivers for Pharmaceutical and make decisions within organization’s guidelines and policies.
• Serve as technical support within your assigned group, collaborating with outside groups as needed.
• Serve as the operations point of contact for campaign start-up CC, site assessment, impact assessment, generation of cGMP documentation, area preparation and summary reporting.
• Audit Support during audits, ensuring smooth communication and providing necessary support and prepare comprehensive responses to audit findings, addressing each point with clarity and accuracy.
• Oversee Corrective and Preventive Actions (CalOOTs), ensuring timely implementation and effectiveness.
• Facilitate and initiate change control processes, including PTCs and EM-PTCs.
• Collaborate with other departments to address corrective actions stemming from audits, inspections.
• Conduct risk assessments and participate in revisions to ensure continuous improvement in compliance efforts.
• Provide support for Quality Assurance Reviews (QAR) and Corrective and Preventive Action (CAPA) plans, ensuring compliance and effectiveness.
• Lead and support in environmental and facility compliance activities, ensuring adherence to regulations and company standards. QAC Requests, CAS Reports to PQS Revisions.
• Analyze control deviations across multiple products and provide insights to the Site Quality Review Team (SQRT).
• Facilitate and Conduct training sessions.
• Monitor safety protocols and procedures on a day-to-day basis to maintain a safe working environment.
• Prepare the manufacturing site for inspections by regulatory agencies through thorough walkthroughs and readiness assessments.
• Conduct compliance walkthroughs for Manufacturing Operations (MamOps) suites to identify and address any non-compliance issues.
• Revising technical documents related to compliance, ensuring accuracy and alignment with current regulations.
• Support procurement and validation of new equipment and technologies for impact assessment.
• Conduct skills training and provide subject matter expertise for training materials.

Requirements:

• Skills: Veeva, Change controls, Risk assessment, SOP revisions, Impact assessments, Investigations and QAR.
• Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience
• OR an associate’s degree with 6 years of experience
• OR a bachelors with at least 2 years of experience
• OR Masters with more than 0-1 year of experience.
• Good verbal communication and ability to coach and provide guidance to others.
• Computer literate, with skills in Microsoft Applications and process tracking software.
• Able to work individually and in a team environment.
• Master’s degree and relevant pharmaceutical experience
• Continuous Improvement or Project Management Certifications.
• Previous experience in a GMP manufacturing environment.
• Familiarity and experience with mammalian cell culture, centrifugation and ultrafiltration.
• BA/BS in chemical engineering, biology, biochemistry or related science or engineering field.
• Minimum of 4+ years relevant experience with an engineering degree or, MS +3 yrs.
• Good verbal communication and ability to coach and provide guidance to others.
• Computer literate, with skills in Microsoft Applications and process tracking software.
• Able to work individually and in a team environment.
• Work will include walking throughout the manufacturing suite including up and down stairs.
• An ability to cross reference multiple documents and perform a detailed review of documentation.

• The engineer/scientist in manufacturing Support operations is responsible for execution of the manufacturing process in a multi-product cGMP facility capable of manufacturing commercial, clinical and development drug substance.
• Additional roles include using operational and technical knowledge to lead, oversee, and evaluate troubleshooting activities, tech transfer and start-up activities, investigations, analyse/interpret process data, and identify and implement complex process improvements.
• Contribute to the completion of projects and manage own time to meet agreed targets.
• Understand the fundamental business drivers for Pharmaceutical and make decisions within organization’s guidelines and policies.
• Serve as technical support within your assigned group, collaborating with outside groups as needed.
• Serve as the operations point of contact for campaign start-up CC, site assessment, impact assessment, generation of cGMP documentation, area preparation and summary reporting.
• Audit Support during audits, ensuring smooth communication and providing necessary support and prepare comprehensive responses to audit findings, addressing each point with clarity and accuracy.
• Oversee Corrective and Preventive Actions (CalOOTs), ensuring timely implementation and effectiveness.
• Facilitate and initiate change control processes, including PTCs and EM-PTCs.
• Collaborate with other departments to address corrective actions stemming from audits, inspections.
• Conduct risk assessments and participate in revisions to ensure continuous improvement in compliance efforts.
• Provide support for Quality Assurance Reviews (QAR) and Corrective and Preventive Action (CAPA) plans, ensuring compliance and effectiveness.
• Lead and support in environmental and facility compliance activities, ensuring adherence to regulations and company standards. QAC Requests, CAS Reports to PQS Revisions.
• Analyze control deviations across multiple products and provide insights to the Site Quality Review Team (SQRT).
• Facilitate and Conduct training sessions.
• Monitor safety protocols and procedures on a day-to-day basis to maintain a safe working environment.
• Prepare the manufacturing site for inspections by regulatory agencies through thorough walkthroughs and readiness assessments.
• Conduct compliance walkthroughs for Manufacturing Operations (MamOps) suites to identify and address any non-compliance issues.
• Revising technical documents related to compliance, ensuring accuracy and alignment with current regulations.
• Support procurement and validation of new equipment and technologies for impact assessment.
• Conduct skills training and provide subject matter expertise for training materials