Project Engineer - III (Senior)
JSG is looking for a Senior Project Engineer for a remote role with 25% travel expected within the Global Development Quality Operations – Drug Product (GDQ Ops) organization.The GDQ Ops team provides critical quality oversight for manufacturing, testing, and release activities associated with clinical-stage Drug Products, ensuring continuous GMP-compliant clinical supply for both internally and externally manufactured supplies.
Working under the direction of GDQ-Ops Supervision, the contractor will play a pivotal, supportive role in quality assurance oversight, product release, document management, and compliance projects within a dynamic, fast-paced R&D environment.Hourly rate $80.00
Responsibilities
- Perform independent quality review and approval of batch records, testing data, and related documents to make independent batch release or reject decisions.
- Conduct independent auditing, review, and approval of complex document types, including deviations, investigations, analytical method validations, method transfers, and certificates of analysis.
- Support compliance activities such as site readiness, health authority audits, and Corrective and Preventive Actions (CAPAs).
- Collect, prepare, and analyze data to support quality system metrics and planning initiatives.
- Perform document management activities, including cataloging records for long-term storage according to retention policies.
- Develop, write, technically edit, or review procedures and other standard documents under Good Manufacturing Practice (GMP) guidelines.
- Support projects aimed at continuous quality improvement, utilizing project management skills as needed.
- Ensure strict compliance with applicable GMP regulations, ICH guidelines, and company policies.
Education
Bachelor degree (B.S.) in an appropriate Science or Engineering discipline (such as engineering, chemistry, biology, biochemistry, or microbiology).
Experience
A minimum of 3 years of experience is preferred. Experience must be within the pharmaceutical, biotechnology, chemical, medical device, or a closely related industry. Demonstrated knowledge of R&D or clinical supply areas, processes, and preferred drug product manufacturing and testing. Background in one or more functional areas such as quality control, quality assurance, laboratory, manufacturing, production, equipment/facilities management, or regulatory. Strong foundational knowledge and expertise in Good Manufacturing Practice (GMP) or related drug regulations.
Additional Information
Candidates must possess strong leadership, collaboration, teamwork, negotiation, and workload management skills to handle rapidly changing R&D needs. Proven ability to work cross-functionally and across various sites with all levels of staff and management is required. Qualified candidates must be proficient with the Microsoft Suite (Word, Excel, PowerPoint, Teams) and show a strong ability to adapt to learning other electronic day-to-day work systems.
Johnson Service Group, Inc. (JSG) is a North American leader in the staffing and consulting services industry, with over 35 years of experience investing in people and companies. Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law. JSG offers medical, dental, vision, life insurance options, short-term disability, 401(k), weekly pay, and more.
Project Engineer - III (Senior)
JSG is looking for a Senior Project Engineer for a remote role with 25% travel expected within the Global Development Quality Operations – Drug Product (GDQ Ops) organization.The GDQ Ops team provides critical quality oversight for manufacturing, testing, and release activities associated with clinical-stage Drug Products, ensuring continuous GMP-compliant clinical supply for both internally and externally manufactured supplies.
Working under the direction of GDQ-Ops Supervision, the contractor will play a pivotal, supportive role in quality assurance oversight, product release, document management, and compliance projects within a dynamic, fast-paced R&D environment.Hourly rate $80.00
Responsibilities
- Perform independent quality review and approval of batch records, testing data, and related documents to make independent batch release or reject decisions.
- Conduct independent auditing, review, and approval of complex document types, including deviations, investigations, analytical method validations, method transfers, and certificates of analysis.
- Support compliance activities such as site readiness, health authority audits, and Corrective and Preventive Actions (CAPAs).
- Collect, prepare, and analyze data to support quality system metrics and planning initiatives.
- Perform document management activities, including cataloging records for long-term storage according to retention policies.
- Develop, write, technically edit, or review procedures and other standard documents under Good Manufacturing Practice (GMP) guidelines.
- Support projects aimed at continuous quality improvement, utilizing project management skills as needed.
- Ensure strict compliance with applicable GMP regulations, ICH guidelines, and company policies.
Education
Bachelor degree (B.S.) in an appropriate Science or Engineering discipline (such as engineering, chemistry, biology, biochemistry, or microbiology).
Experience
A minimum of 3 years of experience is preferred. Experience must be within the pharmaceutical, biotechnology, chemical, medical device, or a closely related industry. Demonstrated knowledge of R&D or clinical supply areas, processes, and preferred drug product manufacturing and testing. Background in one or more functional areas such as quality control, quality assurance, laboratory, manufacturing, production, equipment/facilities management, or regulatory. Strong foundational knowledge and expertise in Good Manufacturing Practice (GMP) or related drug regulations.
Additional Information
Candidates must possess strong leadership, collaboration, teamwork, negotiation, and workload management skills to handle rapidly changing R&D needs. Proven ability to work cross-functionally and across various sites with all levels of staff and management is required. Qualified candidates must be proficient with the Microsoft Suite (Word, Excel, PowerPoint, Teams) and show a strong ability to adapt to learning other electronic day-to-day work systems.
Johnson Service Group, Inc. (JSG) is a North American leader in the staffing and consulting services industry, with over 35 years of experience investing in people and companies. Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law. JSG offers medical, dental, vision, life insurance options, short-term disability, 401(k), weekly pay, and more.
