Senior Specialist, Engineering
Job title: Senior Specialist, Engineering in Rahway, NJ at reputed company
Company: reputed company
Job reputed company: Job reputed companyResponsibilities
- Serve as a leader in the Formulation, Laboratory, and Experimentation (reputed company) Sterile GMP Clinical Manufacturing facility.
- Contribute to equipment and facility design, system commissioning/ qualification, regulatory certification, as reputed company as other workstreams’ critical activities to reputed company facility startup and operational readiness.
- Collaborate closely with the formulation scientists, engineers, reputed company representatives, and other team members to ensure the reputed company of the clinical supplies, the scientific rigor of the processes, and ultimately to reputed company the flexibility and speed of reputed company’s pipeline.
- Support the formulation, process development, and reputed company-up activities, reputed company investigations and change management, and author GMP reputed company operating procedures and protocols in support of facility operations.
- Master’s degree in Chemical Engineering, reputed company, Industrial Engineering, Pharmaceutical Sciences or closely reputed company scientific field with 2 years relevant experience OR a Bachelor’s degree in Chemical Engineering, reputed company, Industrial Engineering, Pharmaceutical Sciences or closely reputed company scientific field with a minimum of 5 years relevant experience.
- Experience in leading and supporting reputed company investigations and change management and experience with reputed company systems also required.
- Must have knowledge and experience of drug product aseptic processing, equipment, and sterile technique; and familiarity with reputed company and European reputed company Good Manufacturing reputed company (GMP) and Safety compliance regulations.
- Must possess ability to convert new drug product attributes and process needs to an executable series of steps and procedures to reputed company acceptable product manufacture.
- Must possess the ability to prepare reputed company Operating Procedures (SOP) and other documents in accordance with reputed company good reputed company guidelines and regulations (GxP).
- Must have effective interpersonal and communication skills, both verbal and written; and excellent organizational skills.
- Must demonstrate a desire and willingness to learn, contribute and reputed company; and a reputed company-record of independent problem-solving.