Project Manager

Responsibilities:

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

Assist in development and review of User Requirements Specifications (URS).

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 validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.

Ensure safety during commissioning, validation, maintenance, and manufacturing activities

Preferred Qualifications / Skills / Experience:

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

2+ years of relevant work experience with 1+ 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

Experience with combination product / medical device quality systems verification

Process equipment knowledge - cell culture, fermentation, purification, filling, and packaging

Process automation knowledge - understanding of automation infrastructure, current technologies, and automation project execution / verification.

Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus

Demonstrated strong communication and technical writing skills

Strengths in facilitation and collaboration / networking

Top 3 Must Have Skill Sets:

Good Fundamental Leadership and Values

Good Fundamental Engineering

Good Fundamental Project Management

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, 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.