Aditi Consulting
Project Manager
Aditi Consulting, Thousand Oaks, California, United States, 91362
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 resourcesProvide oversight for verification deliverables developed by outsourced/contract verification staff.Act as a liaison between Engineering and Quality Assurance during project planning, execution, and closeoutEnsure 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 field2+ years of relevant work experience with 1+ years’ experience in operations/manufacturing environmentDirect 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 equipmentExperience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and executionExperience with combination product / medical device quality systems verificationProcess equipment knowledge – cell culture, fermentation, purification, filling, and packagingProcess automation knowledge – understanding of automation infrastructure, current technologies, and automation project execution / verification.Knowledge of Delta V, Rockwell, and Plant Information Systems is a plusDemonstrated strong communication and technical writing skillsStrengths in facilitation and collaboration / networking
Top 3 Must Have Skill Sets:
Good Fundamental Leadership and ValuesGood Fundamental EngineeringGood 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.#J-18808-Ljbffr
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 resourcesProvide oversight for verification deliverables developed by outsourced/contract verification staff.Act as a liaison between Engineering and Quality Assurance during project planning, execution, and closeoutEnsure 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 field2+ years of relevant work experience with 1+ years’ experience in operations/manufacturing environmentDirect 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 equipmentExperience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and executionExperience with combination product / medical device quality systems verificationProcess equipment knowledge – cell culture, fermentation, purification, filling, and packagingProcess automation knowledge – understanding of automation infrastructure, current technologies, and automation project execution / verification.Knowledge of Delta V, Rockwell, and Plant Information Systems is a plusDemonstrated strong communication and technical writing skillsStrengths in facilitation and collaboration / networking
Top 3 Must Have Skill Sets:
Good Fundamental Leadership and ValuesGood Fundamental EngineeringGood 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.#J-18808-Ljbffr