Process Engineer II

Job summary:

Work requires independent evaluation, selection and application of standard engineering techniques, procedures, and criteria, using judgment and ingenuity in making minor 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 limited scope.  Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, and company practices and policies.

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 and final documentation in accordance with acceptable engineering practices.
• 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 engineering skill(s).
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

Education:

• Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Engineering, preferred.

Licenses or certifications:

• N/A.

Experience:

• Minimum 2 years’ experience.
• Two years of GMP manufacturing experience required.

Job summary:

Work requires independent evaluation, selection and application of standard engineering techniques, procedures, and criteria, using judgment and ingenuity in making minor 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 limited scope.  Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, and company practices and policies.

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 and final documentation in accordance with acceptable engineering practices.
• 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 engineering skill(s).
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

Education:

• Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Engineering, preferred.

Licenses or certifications:

• N/A.

Experience:

• Minimum 2 years’ experience.
• Two years of GMP manufacturing experience required.

Job summary:

Work requires independent evaluation, selection and application of standard engineering techniques, procedures, and criteria, using judgment and ingenuity in making minor 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 limited scope.  Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, and company practices and policies.

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 and final documentation in accordance with acceptable engineering practices.
• 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 engineering skill(s).
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

Education:

• Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Bachelor of Science Degree in Engineering, preferred.

Licenses or certifications:

• N/A.

Experience:

• Minimum 2 years’ experience.
• Two years of GMP manufacturing experience required.