Microbiology Quality Engineer II

Job summary:

Work requires independent evaluation, selection and application of standard engineering techniques, procedures, and criteria, using judgment and ingenuity in making adaptations and modifications.  Assignments include equipment design and development, tests of materials, preparation of specifications, process study, research investigations, report preparation and other activities of specific scope.  Duties are assigned based on experience and familiarization with microbiology and engineering methods, independent thinking, and medical industry practices and standards.

Essential duties:

• Provides specification, procurement, installation, start-up, and commissioning activities for manufacturing equipment, facilities areas, and process utilities systems.
• Manages projects including development of project scope and estimates, initiation of requests for capital when required, specification of equipment and installation requirements, management of costs to budget, and support of IQ/OQ/PQ and final documentation in accordance with acceptable microbiology and engineering practices.
• Solve investigation events like NCs, CAPAs, validations, implementation of laboratory methodologies and train lab personnel as part of these processes.
• Act as science microbiology and sterilization support for external audit.
• Conducts studies and makes recommendations for the purchase and implementation of new technologies, practices, tools, and equipment to maximize site effectiveness.
• Prepares and reviews engineering/technical documents such as reports, SOP’s, protocols, schedules and budgets, and vendor provided documents and drawings.
• Ensures that process and equipment designs are compliant with all Company policies and procedures as well as all Local, State, and Federal directives, laws and regulations.
• Provides work direction to engineering support staff.
• Takes initiative and demonstrates inquisitive approaches to solve moderately complex problems, identifying problems, generating alternatives and recommending solutions.
• Follows department processes and regularly makes recommendations on these processes.
• Follows technical specification requirements, developing reports, charts and graphs to support project recommendations and responds to questions from technical staff members and management.
• Works cooperatively and effectively in a team environment or across teams to achieve common goals and results.
• Analyzes data and presents it in appropriate forums.
• Actively participates in Quality System and Good Laboratory Practice requirements, particularly with respect to documentation.
• Work assignments may require additional development and a maturing or broadening of in-depth microbiology and engineering skill(s).
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

Education:

• Bachelor’s degree of science or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Microbiology, Biotechnology or Engineering, preferred.
• English intermediate level (written and speak) able to communicate and coordinate activities with foreign partners.

Licenses or certifications:

• N/A

Experience:

• Minimum 2 years of experience in medical devices, pharmacy or sterilization process.

Job summary:

Work requires independent evaluation, selection and application of standard engineering techniques, procedures, and criteria, using judgment and ingenuity in making adaptations and modifications.  Assignments include equipment design and development, tests of materials, preparation of specifications, process study, research investigations, report preparation and other activities of specific scope.  Duties are assigned based on experience and familiarization with microbiology and engineering methods, independent thinking, and medical industry practices and standards.

Essential duties:

• Provides specification, procurement, installation, start-up, and commissioning activities for manufacturing equipment, facilities areas, and process utilities systems.
• Manages projects including development of project scope and estimates, initiation of requests for capital when required, specification of equipment and installation requirements, management of costs to budget, and support of IQ/OQ/PQ and final documentation in accordance with acceptable microbiology and engineering practices.
• Solve investigation events like NCs, CAPAs, validations, implementation of laboratory methodologies and train lab personnel as part of these processes.
• Act as science microbiology and sterilization support for external audit.
• Conducts studies and makes recommendations for the purchase and implementation of new technologies, practices, tools, and equipment to maximize site effectiveness.
• Prepares and reviews engineering/technical documents such as reports, SOP’s, protocols, schedules and budgets, and vendor provided documents and drawings.
• Ensures that process and equipment designs are compliant with all Company policies and procedures as well as all Local, State, and Federal directives, laws and regulations.
• Provides work direction to engineering support staff.
• Takes initiative and demonstrates inquisitive approaches to solve moderately complex problems, identifying problems, generating alternatives and recommending solutions.
• Follows department processes and regularly makes recommendations on these processes.
• Follows technical specification requirements, developing reports, charts and graphs to support project recommendations and responds to questions from technical staff members and management.
• Works cooperatively and effectively in a team environment or across teams to achieve common goals and results.
• Analyzes data and presents it in appropriate forums.
• Actively participates in Quality System and Good Laboratory Practice requirements, particularly with respect to documentation.
• Work assignments may require additional development and a maturing or broadening of in-depth microbiology and engineering skill(s).
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

Education:

• Bachelor’s degree of science or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Microbiology, Biotechnology or Engineering, preferred.
• English intermediate level (written and speak) able to communicate and coordinate activities with foreign partners.

Licenses or certifications:

• N/A

Experience:

• Minimum 2 years of experience in medical devices, pharmacy or sterilization process.

Job summary:

Work requires independent evaluation, selection and application of standard engineering techniques, procedures, and criteria, using judgment and ingenuity in making adaptations and modifications.  Assignments include equipment design and development, tests of materials, preparation of specifications, process study, research investigations, report preparation and other activities of specific scope.  Duties are assigned based on experience and familiarization with microbiology and engineering methods, independent thinking, and medical industry practices and standards.

Essential duties:

• Provides specification, procurement, installation, start-up, and commissioning activities for manufacturing equipment, facilities areas, and process utilities systems.
• Manages projects including development of project scope and estimates, initiation of requests for capital when required, specification of equipment and installation requirements, management of costs to budget, and support of IQ/OQ/PQ and final documentation in accordance with acceptable microbiology and engineering practices.
• Solve investigation events like NCs, CAPAs, validations, implementation of laboratory methodologies and train lab personnel as part of these processes.
• Act as science microbiology and sterilization support for external audit.
• Conducts studies and makes recommendations for the purchase and implementation of new technologies, practices, tools, and equipment to maximize site effectiveness.
• Prepares and reviews engineering/technical documents such as reports, SOP’s, protocols, schedules and budgets, and vendor provided documents and drawings.
• Ensures that process and equipment designs are compliant with all Company policies and procedures as well as all Local, State, and Federal directives, laws and regulations.
• Provides work direction to engineering support staff.
• Takes initiative and demonstrates inquisitive approaches to solve moderately complex problems, identifying problems, generating alternatives and recommending solutions.
• Follows department processes and regularly makes recommendations on these processes.
• Follows technical specification requirements, developing reports, charts and graphs to support project recommendations and responds to questions from technical staff members and management.
• Works cooperatively and effectively in a team environment or across teams to achieve common goals and results.
• Analyzes data and presents it in appropriate forums.
• Actively participates in Quality System and Good Laboratory Practice requirements, particularly with respect to documentation.
• Work assignments may require additional development and a maturing or broadening of in-depth microbiology and engineering skill(s).
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

Education:

• Bachelor’s degree of science or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Microbiology, Biotechnology or Engineering, preferred.
• English intermediate level (written and speak) able to communicate and coordinate activities with foreign partners.

Licenses or certifications:

• N/A

Experience:

• Minimum 2 years of experience in medical devices, pharmacy or sterilization process.