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Posted : Friday, May 24, 2024 08:18 PM
JOB DESCRIPTION
Company:
PBS Biotech, Inc.
Department: Quality Position/Title: Quality Engineer Location: Camarillo, CA Reporting To: Exec.
Director Quality FLSA Status: Exempt Pay Range: $102k - $111k - $120k GENERAL PURPOSE The Quality Engineer is responsible for providing technical and compliance analysis for product and process for quality related functions such as Nonconformance, Complaints, CAPA, and Change Record Management.
This role supports tech transfer, manufacturing, and process/product improvement of bioreactors and single-use products.
Knowledge and experience with engineering and technical methods as well as the Quality Management System (QMS) is required.
Additional leadership and project assignments will be assigned based on needs of the business.
RESPONSIBILITIES Essential functions of the job are listed below.
Other responsibilities may also be assigned.
Please note that the essential functions may vary depending on department size, organizational structure and/or geographic location.
Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.
Primary Responsibilities Provide technical and Quality Engineering analysis and assessments for impact to product quality, comparability, and root cause analysis to support change orders, nonconformances (investigations), CAPA, validation/verification, and manufacturing processes.
Perform or manage corrective actions to support CAPAs, maintaining and revising Quality Systems documents, to include but not limited to manuals, procedures, work instructions, forms, etc.
May be assigned to perform QA approvals, including ensuring that corrective measures meet acceptable criteria or standards, and that documentation is compliant with QA requirements.
Quality Owner for CAPA or Change Records of manufacturing process and equipment as a result from NCs or Complaints and meeting QMS record deadlines.
Responsible for continuous improvements of assigned processes.
Identify opportunities for and lead or participate in continuous improvement of the QMS program, which may include seeking feedback from stakeholders.
Liaise between the Engineering and Quality departments to provide support of Engineering projects and to identify and coordinate improvements.
Supports or manages procedure updates and improvements.
Will be assigned additional tasks and projects as needed to meet business objectives.
MINIMUM QUALIFICATIONS The following are the minimum qualifications that an individual needs in order to successfully perform the duties and responsibilities of this position.
Please note that the minimum qualifications may vary based upon the department size and/or geographic location.
The position requires experience with developing and validating medical devices, GMP bioprocessing equipment, or single-use medical products and requires the application of Quality Engineering methods and tools to define requirements for testing, verification, qualification, and validation.
This role requires effective leadership, collaboration, technical writing, and verbal communication skills.
Knowledge/ Experience Minimum 2 years in a Quality Engineering or 3 years in a related role such as Commercial Product Engineering, Manufacturing Engineering, or Industrial Engineering or similar role.
Minimum 2 years of experience working in a quality system with products regulated by GMP/Biopharma (21 CFR 210/211, ICH Q7/10) or medical device (ISO 13485), or similar medical products field.
Advanced skills with MS Office applications Word, Excel, as well as Adobe Acrobat.
Experience interfacing with engineers to perform tech transfer, data analysis and statistical methods, verification/validation.
Excellent verbal and written communication skills including excellent technical writing skills.
A bachelor’s degree in an Engineering discipline or related science field with 3 years of relevant industry experience.
Skills/ Abilities Pertinent to This Position Experience with a quality management system in drug/biotech/pharma (21CFR210/211), medical devices (21 CFR 820, ISO 13485/14971) or medical products (ISO 9001, ISO 13485).
Experience with polymer processing – injection molding, machining, and extrusion.
Experience with assembly and testing of medical products or drug product manufacturing.
Experience with product development, tech transfer, and manufacturing process control.
Experience with software, computerized systems, and/or control system validation.
Experience using one or more engineering tools and methods such as CAD, statistical analysis (Minitab, JMP, SigmaXL, SAS, R, Matlab, Dataplot, or equivalent), statistical sampling/acceptance methods (ANSI, MIL-STD, AQL), design of experiments, design control, DFM, etc.
Excellent technical writing and excellent verbal communication skills PHYSICAL DEMANDS In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.
Must be able to see, hear, speak and write clearly in order to communicate with employees and/or vendors; manual dexterity required for occasional reaching and lifting of small objects, and operating manufacturing and test equipment.
May occasionally required to lift various weights up to 20 lbs as needed to meet job requirements.
WORK ENVIRONMENT In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job.
Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job within the environment.
This role is primarily office work with some tasks or evaluation performed in a production or lab-like environment.
May be required to perform some tasks in the following environments: Clean room; Near moving mechanical parts, fumes, machine lubricants, airborne particles, vibration, and risk of electrical shock, high noise while in the manufacturing plant.
Personal protective equipment (vision and hearing) used in plant.
NXTThing RPO is an Equal Opportunity Employer.
Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
cPbXvdtdLK
Department: Quality Position/Title: Quality Engineer Location: Camarillo, CA Reporting To: Exec.
Director Quality FLSA Status: Exempt Pay Range: $102k - $111k - $120k GENERAL PURPOSE The Quality Engineer is responsible for providing technical and compliance analysis for product and process for quality related functions such as Nonconformance, Complaints, CAPA, and Change Record Management.
This role supports tech transfer, manufacturing, and process/product improvement of bioreactors and single-use products.
Knowledge and experience with engineering and technical methods as well as the Quality Management System (QMS) is required.
Additional leadership and project assignments will be assigned based on needs of the business.
RESPONSIBILITIES Essential functions of the job are listed below.
Other responsibilities may also be assigned.
Please note that the essential functions may vary depending on department size, organizational structure and/or geographic location.
Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.
Primary Responsibilities Provide technical and Quality Engineering analysis and assessments for impact to product quality, comparability, and root cause analysis to support change orders, nonconformances (investigations), CAPA, validation/verification, and manufacturing processes.
Perform or manage corrective actions to support CAPAs, maintaining and revising Quality Systems documents, to include but not limited to manuals, procedures, work instructions, forms, etc.
May be assigned to perform QA approvals, including ensuring that corrective measures meet acceptable criteria or standards, and that documentation is compliant with QA requirements.
Quality Owner for CAPA or Change Records of manufacturing process and equipment as a result from NCs or Complaints and meeting QMS record deadlines.
Responsible for continuous improvements of assigned processes.
Identify opportunities for and lead or participate in continuous improvement of the QMS program, which may include seeking feedback from stakeholders.
Liaise between the Engineering and Quality departments to provide support of Engineering projects and to identify and coordinate improvements.
Supports or manages procedure updates and improvements.
Will be assigned additional tasks and projects as needed to meet business objectives.
MINIMUM QUALIFICATIONS The following are the minimum qualifications that an individual needs in order to successfully perform the duties and responsibilities of this position.
Please note that the minimum qualifications may vary based upon the department size and/or geographic location.
The position requires experience with developing and validating medical devices, GMP bioprocessing equipment, or single-use medical products and requires the application of Quality Engineering methods and tools to define requirements for testing, verification, qualification, and validation.
This role requires effective leadership, collaboration, technical writing, and verbal communication skills.
Knowledge/ Experience Minimum 2 years in a Quality Engineering or 3 years in a related role such as Commercial Product Engineering, Manufacturing Engineering, or Industrial Engineering or similar role.
Minimum 2 years of experience working in a quality system with products regulated by GMP/Biopharma (21 CFR 210/211, ICH Q7/10) or medical device (ISO 13485), or similar medical products field.
Advanced skills with MS Office applications Word, Excel, as well as Adobe Acrobat.
Experience interfacing with engineers to perform tech transfer, data analysis and statistical methods, verification/validation.
Excellent verbal and written communication skills including excellent technical writing skills.
A bachelor’s degree in an Engineering discipline or related science field with 3 years of relevant industry experience.
Skills/ Abilities Pertinent to This Position Experience with a quality management system in drug/biotech/pharma (21CFR210/211), medical devices (21 CFR 820, ISO 13485/14971) or medical products (ISO 9001, ISO 13485).
Experience with polymer processing – injection molding, machining, and extrusion.
Experience with assembly and testing of medical products or drug product manufacturing.
Experience with product development, tech transfer, and manufacturing process control.
Experience with software, computerized systems, and/or control system validation.
Experience using one or more engineering tools and methods such as CAD, statistical analysis (Minitab, JMP, SigmaXL, SAS, R, Matlab, Dataplot, or equivalent), statistical sampling/acceptance methods (ANSI, MIL-STD, AQL), design of experiments, design control, DFM, etc.
Excellent technical writing and excellent verbal communication skills PHYSICAL DEMANDS In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.
Must be able to see, hear, speak and write clearly in order to communicate with employees and/or vendors; manual dexterity required for occasional reaching and lifting of small objects, and operating manufacturing and test equipment.
May occasionally required to lift various weights up to 20 lbs as needed to meet job requirements.
WORK ENVIRONMENT In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job.
Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job within the environment.
This role is primarily office work with some tasks or evaluation performed in a production or lab-like environment.
May be required to perform some tasks in the following environments: Clean room; Near moving mechanical parts, fumes, machine lubricants, airborne particles, vibration, and risk of electrical shock, high noise while in the manufacturing plant.
Personal protective equipment (vision and hearing) used in plant.
NXTThing RPO is an Equal Opportunity Employer.
Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
cPbXvdtdLK
• Phone : NA
• Location : Camarillo, CA
• Post ID: 9023764033
