Engineer

Summary:

The senior engineer works in partnership with the automation, maintenance, project management, corporate engineering, and manufacturing to develop and oversee the operation and reliability of equipment while driving safety and quality compliance. The engineer will support the department and capital projects and provide data to support business cases and long-term strategy.

Responsibilities:

Demonstrating role modeling of leadership behaviors and positive values to create a positive working environment.

Be individually accountable for manufacturing equipment reliability and deliverables on key capital projects to deliver business targets and deliverables

Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.

Suggest design modifications to address risks and design in quality and safety.

Develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (risk-based approach).

Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and cGMP standards.

Recommend, evaluate, and manage performance of contract resources

Provide oversight for verification deliverables developed by outsourced/contract verification staff.

Act as a liaison between engineering and quality assurance during project planning, execution, and closeout

Ensure that work executed with safety compliant practices and documented in accordance with cGMP good documentation

Basic Qualifications:

Doctorate degree OR Master's degree & 3 years of engineering and/or manufacturing experience OR Bachelor's degree & 5 years of engineering and/or manufacturing experience OR Associate's degree & 10 years of engineering and/or manufacturing experience OR High school diploma / GED & 12 years of engineering and/or manufacturing experience

Preferred Qualifications / Skills / Experience

Bachelor's degree in engineering or another science-related field

7+ years of relevant work experience with 5+ years' experience in operations/manufacturing environment

Direct experience with regulated environments (FDA, OSHA, EPA, etc.)

Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment

Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution

Compensation:

The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, competencies, competencies, competencies, experience, location and end client requirements).

Benefits and Ancillaries:

Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.