agrazela
Well-Known Member
The following cut-and-pasted straight from our intranet site. PM if interested.
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Quality Engineer
Job ID #: 850 Location: CA - San Diego
Functional Area: Manufacturing Facility:
Position Type: Full-Time Regular Department: 810300 - San Diego Plant
Education Required: Not Indicated Salary Grade:
Experience Required: 5 - 7 Years Relocation Provided: Limited
Position Description
Reporting to the facility Quality Manager and indirectly to Global Director QA, QMS, Food Safety is responsible to provide leadership and direction for cGMP and food safety engineering to Maintenance, Engineering, and Operations Departments.
Will oversee the implementation of the facilitys food safety plan, HACCP to HARPC transition and assure facility meets FSMA Section 103 Preventive Controls and Supplier Controls regulatory requirement.
Maintain awareness of the food regulatory environment and emerging microorganisms of concern
Provides support for areas such as CAPA/Nonconformance Investigations, Customer Complaints and Audits and leads validation of corrective actions that meet CAPA closed-loop regulatory requirements of FDA registered food or pharmaceutical manufacturing facilities.
Leads the plant Food Safety Management System in a manner which will ensure compliance with regulatory, quality system and customer requirements. This includes a thorough evaluation of building infrastructure and expansion or upgrading facilities and food contact equipment to assure that quality and food safety are built into all new/upgraded equipment or structures.
Supports the plant QA manager in continuous improvement activities of the Quality Management System
Leads facilities with focus on cGMP and adequacy of the areas after the completion of the work and supervision to ensure that all the work was completed, and improvements to meet the GMP guidelines/food safety, commissioning and validation activities and evaluation of HACCP plans/HARPC.
Leads all product adulteration incident reviews and provides leadership in micro management and sanitation excellence.
Strong knowledge of FSMA Preventive Controls requirement and development of Food Safety Plans with experience driving corrective actions of food safety issues
Capable of influencing people while managing issues with a wide variety of internal and external partners
Dimensions of Job:
As the Food Safety leader for the facility work with the Global Director QA, QMS and Food Safety Director to drive implementation of the Global Food Safety Policy and improvements needed to meet final FSMA regulatory requirements.
Communicate cGMP risk and improvements to Global Director QA, QMS and Food Safety and plant Management to proactively respond to changing requirements
Is point person for Food Safety and FSMA and other regulatory requirement related questions
Manage and focus directly on cGMP food safety engineering/food security and validation, in preparation for the commercial production of regulated products. Lead projects of facilities and equipment and optimization of existing manufacturing processes to deliver products with the production requirements consistent with the requirements of the regulatory FDA/Global products.
Conduct gap assessment and establish (define, develop/implement) preventive control requirements and monitoring requirements to comply to FSMA regulations
Support strategic plans for improvement of plant and processes, in order to increase efficiency, reduce costs, but make sure that quality, cGMP and food safety are designed in equipment before commissioning.
Detail oriented with demonstrate ability to identify critical data and distill into business-focused technical recommendations
Leading and delivering projects, monitoring progress against goals, identifies issues and takes corrective actions early.
Ability to achieve quality and food safety results consistently despite obstacles
Principal Duties and Responsibilities:
Lead validation function to ensure that facilities, utilities and the qualifications of the process equipment are carried out to meet global regulatory requirements.
Guide in the specification and selection of manufacturing/equipment and product contact surfaces and ensure that the equipment purchased meets the regulatory requirements of the product and packaging.
Cultivate a high regards for cGMP and food safety as the leader to train employees to create awareness to meet regulatory requirements.
Motivate, develop and recruit key employees for the food safety team. Build and maintain employee engagement, creating a culture of efficient execution and an environment in which individuals and teams can stand out and continuously improve and develop an awareness of quality, GMP and food safety.
Maximize the success rate in production operations by recommending programs for preventive and predictive maintenance, and ensure that all SSOPs and HACCP plans/HARPC be reviewed and updated, if necessary.Support environmental protection programs, preventive maintenance and plant safety, metrology and industrial hygiene to work effectively and to meet the compliance requirements of Regulatory Agency.
Optimize the documentation for quality systems engineering, cleaning and validation SOPS, SSOPs, HACCP plans and food safety policy and protocols.
Lead incident reviews to investigate and correct microbiological, physical and chemical product non-conformities and provide recommendation regarding process design, product disposition and continuous improvement.
Communicate with business partners and senior management in order to identify and implement any equipment or resources needed for new processes
Lead HARPC risk assessment for all new lines and as needed to update Food Safety Policy
Qualifications/Skills:
Minimum of 5-7 years experience in Food Microbiology, Process Development and Quality and Food Safety Management Systems
Bachelor of Science Degree (i.e. Process Engineering, Chemistry, Microbiology, Food Safety) required; MS preferred
ASQ Quality Engineer Certification
ASQ Certified Black Belt or Green Belt preferred
Certified HACCP manager required; Certified in Food Preventive Controls preferred
Knowledge of food microbiology, good laboratory practice, food safety controls, manufacturing processes, sanitary design, food law, cGMP, auditing, troubleshooting and microbiological test procedures is required.
Experienced with implementing management systems in the CPG Industry-ISO 9001, 22000, 22002 background with accomplishments in design and implementation
Demonstrated leadership in QA, Quality and Food Safety Management Systems, New Product Development and Food or Pharmaceutical manufacturing
Ability to successfully lead people through change and transformation in a diverse global fast paced organization
Displayed proficiency in developing mutual respect with operators, mechanics, fork lift drivers and maintenance in order to create awareness to Food Safety regulations and execute programs and achieve goals to meet regulatory requirements
Demonstrated experience in root cause analysis and CAPA
Strong computer skills with proven proficiency in Microsoft Word, Excel, Power Point and flowcharting software
Ability to lead constructive, positive change within a plant environment.
Be able to display proficiency in developing mutual respect with operators, mechanics, fork lift drivers, etc in order to execute programs and achieve goals.
Show ability to lead peer group and effect change/department direction via influence management.
Ability to communicate with leadership team to gain broad support for ideas.
Clear, concise, well directed communication.
Ability to be flexible with work hours, shifting priorities, ambiguity. Maximize the success rate in production operations by recommending programs for preventive and predictive maintenance, and ensure that all SSOPs and HACCP plans/HARPC be reviewed and updated, if necessary.Support environmental protection programs, preventive maintenance and plant safety, metrology and industrial hygiene to work effectively and to meet the compliance requirements of Regulatory Agency.
Optimize the documentation for quality systems engineering, cleaning and validation SOPS, SSOPs, HACCP plans and food safety policy and protocols.
Lead incident reviews to investigate and correct microbiological, physical and chemical product non-conformities and provide recommendation regarding process design, product disposition and continuous improvement.
Communicate with business partners and senior management in order to identify and implement any equipment or resources needed for new processes
Lead HARPC risk assessment for all new lines and as needed to update Food Safety Policy
Position Requirements
Qualifications/Skills:
Minimum of 5-7 years experience in Food Microbiology, Process Development and Quality and Food Safety Management Systems
Bachelor of Science Degree (i.e. Process Engineering, Chemistry, Microbiology, Food Safety) required; MS preferred
ASQ Quality Engineer Certification
ASQ Certified Black Belt or Green Belt preferred
Certified HACCP manager required; Certified in Food Preventive Controls preferred
Knowledge of food microbiology, good laboratory practice, food safety controls, manufacturing processes, sanitary design, food law, cGMP, auditing, troubleshooting and microbiological test procedures is required.
Experienced with implementing management systems in the CPG Industry-ISO 9001, 22000, 22002 background with accomplishments in design and implementation
Demonstrated leadership in QA, Quality and Food Safety Management Systems, New Product Development and Food or Pharmaceutical manufacturing
Ability to successfully lead people through change and transformation in a diverse global fast paced organization
Displayed proficiency in developing mutual respect with operators, mechanics, fork lift drivers and maintenance in order to create awareness to Food Safety regulations and execute programs and achieve goals to meet regulatory requirements
Demonstrated experience in root cause analysis and CAPA
Strong computer skills with proven proficiency in Microsoft Word, Excel, Power Point and flowcharting software
Ability to lead constructive, positive change within a plant environment.
Be able to display proficiency in developing mutual respect with operators, mechanics, fork lift drivers, etc in order to execute programs and achieve goals.
Show ability to lead peer group and effect change/department direction via influence management.
Ability to communicate with leadership team to gain broad support for ideas.
Clear, concise, well directed communication.
Ability to be flexible with work hours, shifting priorities, ambiguity.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
==========
Quality Engineer
Job ID #: 850 Location: CA - San Diego
Functional Area: Manufacturing Facility:
Position Type: Full-Time Regular Department: 810300 - San Diego Plant
Education Required: Not Indicated Salary Grade:
Experience Required: 5 - 7 Years Relocation Provided: Limited
Position Description
Reporting to the facility Quality Manager and indirectly to Global Director QA, QMS, Food Safety is responsible to provide leadership and direction for cGMP and food safety engineering to Maintenance, Engineering, and Operations Departments.
Will oversee the implementation of the facilitys food safety plan, HACCP to HARPC transition and assure facility meets FSMA Section 103 Preventive Controls and Supplier Controls regulatory requirement.
Maintain awareness of the food regulatory environment and emerging microorganisms of concern
Provides support for areas such as CAPA/Nonconformance Investigations, Customer Complaints and Audits and leads validation of corrective actions that meet CAPA closed-loop regulatory requirements of FDA registered food or pharmaceutical manufacturing facilities.
Leads the plant Food Safety Management System in a manner which will ensure compliance with regulatory, quality system and customer requirements. This includes a thorough evaluation of building infrastructure and expansion or upgrading facilities and food contact equipment to assure that quality and food safety are built into all new/upgraded equipment or structures.
Supports the plant QA manager in continuous improvement activities of the Quality Management System
Leads facilities with focus on cGMP and adequacy of the areas after the completion of the work and supervision to ensure that all the work was completed, and improvements to meet the GMP guidelines/food safety, commissioning and validation activities and evaluation of HACCP plans/HARPC.
Leads all product adulteration incident reviews and provides leadership in micro management and sanitation excellence.
Strong knowledge of FSMA Preventive Controls requirement and development of Food Safety Plans with experience driving corrective actions of food safety issues
Capable of influencing people while managing issues with a wide variety of internal and external partners
Dimensions of Job:
As the Food Safety leader for the facility work with the Global Director QA, QMS and Food Safety Director to drive implementation of the Global Food Safety Policy and improvements needed to meet final FSMA regulatory requirements.
Communicate cGMP risk and improvements to Global Director QA, QMS and Food Safety and plant Management to proactively respond to changing requirements
Is point person for Food Safety and FSMA and other regulatory requirement related questions
Manage and focus directly on cGMP food safety engineering/food security and validation, in preparation for the commercial production of regulated products. Lead projects of facilities and equipment and optimization of existing manufacturing processes to deliver products with the production requirements consistent with the requirements of the regulatory FDA/Global products.
Conduct gap assessment and establish (define, develop/implement) preventive control requirements and monitoring requirements to comply to FSMA regulations
Support strategic plans for improvement of plant and processes, in order to increase efficiency, reduce costs, but make sure that quality, cGMP and food safety are designed in equipment before commissioning.
Detail oriented with demonstrate ability to identify critical data and distill into business-focused technical recommendations
Leading and delivering projects, monitoring progress against goals, identifies issues and takes corrective actions early.
Ability to achieve quality and food safety results consistently despite obstacles
Principal Duties and Responsibilities:
Lead validation function to ensure that facilities, utilities and the qualifications of the process equipment are carried out to meet global regulatory requirements.
Guide in the specification and selection of manufacturing/equipment and product contact surfaces and ensure that the equipment purchased meets the regulatory requirements of the product and packaging.
Cultivate a high regards for cGMP and food safety as the leader to train employees to create awareness to meet regulatory requirements.
Motivate, develop and recruit key employees for the food safety team. Build and maintain employee engagement, creating a culture of efficient execution and an environment in which individuals and teams can stand out and continuously improve and develop an awareness of quality, GMP and food safety.
Maximize the success rate in production operations by recommending programs for preventive and predictive maintenance, and ensure that all SSOPs and HACCP plans/HARPC be reviewed and updated, if necessary.Support environmental protection programs, preventive maintenance and plant safety, metrology and industrial hygiene to work effectively and to meet the compliance requirements of Regulatory Agency.
Optimize the documentation for quality systems engineering, cleaning and validation SOPS, SSOPs, HACCP plans and food safety policy and protocols.
Lead incident reviews to investigate and correct microbiological, physical and chemical product non-conformities and provide recommendation regarding process design, product disposition and continuous improvement.
Communicate with business partners and senior management in order to identify and implement any equipment or resources needed for new processes
Lead HARPC risk assessment for all new lines and as needed to update Food Safety Policy
Qualifications/Skills:
Minimum of 5-7 years experience in Food Microbiology, Process Development and Quality and Food Safety Management Systems
Bachelor of Science Degree (i.e. Process Engineering, Chemistry, Microbiology, Food Safety) required; MS preferred
ASQ Quality Engineer Certification
ASQ Certified Black Belt or Green Belt preferred
Certified HACCP manager required; Certified in Food Preventive Controls preferred
Knowledge of food microbiology, good laboratory practice, food safety controls, manufacturing processes, sanitary design, food law, cGMP, auditing, troubleshooting and microbiological test procedures is required.
Experienced with implementing management systems in the CPG Industry-ISO 9001, 22000, 22002 background with accomplishments in design and implementation
Demonstrated leadership in QA, Quality and Food Safety Management Systems, New Product Development and Food or Pharmaceutical manufacturing
Ability to successfully lead people through change and transformation in a diverse global fast paced organization
Displayed proficiency in developing mutual respect with operators, mechanics, fork lift drivers and maintenance in order to create awareness to Food Safety regulations and execute programs and achieve goals to meet regulatory requirements
Demonstrated experience in root cause analysis and CAPA
Strong computer skills with proven proficiency in Microsoft Word, Excel, Power Point and flowcharting software
Ability to lead constructive, positive change within a plant environment.
Be able to display proficiency in developing mutual respect with operators, mechanics, fork lift drivers, etc in order to execute programs and achieve goals.
Show ability to lead peer group and effect change/department direction via influence management.
Ability to communicate with leadership team to gain broad support for ideas.
Clear, concise, well directed communication.
Ability to be flexible with work hours, shifting priorities, ambiguity. Maximize the success rate in production operations by recommending programs for preventive and predictive maintenance, and ensure that all SSOPs and HACCP plans/HARPC be reviewed and updated, if necessary.Support environmental protection programs, preventive maintenance and plant safety, metrology and industrial hygiene to work effectively and to meet the compliance requirements of Regulatory Agency.
Optimize the documentation for quality systems engineering, cleaning and validation SOPS, SSOPs, HACCP plans and food safety policy and protocols.
Lead incident reviews to investigate and correct microbiological, physical and chemical product non-conformities and provide recommendation regarding process design, product disposition and continuous improvement.
Communicate with business partners and senior management in order to identify and implement any equipment or resources needed for new processes
Lead HARPC risk assessment for all new lines and as needed to update Food Safety Policy
Position Requirements
Qualifications/Skills:
Minimum of 5-7 years experience in Food Microbiology, Process Development and Quality and Food Safety Management Systems
Bachelor of Science Degree (i.e. Process Engineering, Chemistry, Microbiology, Food Safety) required; MS preferred
ASQ Quality Engineer Certification
ASQ Certified Black Belt or Green Belt preferred
Certified HACCP manager required; Certified in Food Preventive Controls preferred
Knowledge of food microbiology, good laboratory practice, food safety controls, manufacturing processes, sanitary design, food law, cGMP, auditing, troubleshooting and microbiological test procedures is required.
Experienced with implementing management systems in the CPG Industry-ISO 9001, 22000, 22002 background with accomplishments in design and implementation
Demonstrated leadership in QA, Quality and Food Safety Management Systems, New Product Development and Food or Pharmaceutical manufacturing
Ability to successfully lead people through change and transformation in a diverse global fast paced organization
Displayed proficiency in developing mutual respect with operators, mechanics, fork lift drivers and maintenance in order to create awareness to Food Safety regulations and execute programs and achieve goals to meet regulatory requirements
Demonstrated experience in root cause analysis and CAPA
Strong computer skills with proven proficiency in Microsoft Word, Excel, Power Point and flowcharting software
Ability to lead constructive, positive change within a plant environment.
Be able to display proficiency in developing mutual respect with operators, mechanics, fork lift drivers, etc in order to execute programs and achieve goals.
Show ability to lead peer group and effect change/department direction via influence management.
Ability to communicate with leadership team to gain broad support for ideas.
Clear, concise, well directed communication.
Ability to be flexible with work hours, shifting priorities, ambiguity.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
