Job requirement will include ability to perform in the aseptic environment. Wear personal protective equipment, such as eye, foot, lab coat, mask, gowning coveralls.
- Perform equipment Installation, Operational, and Performance Qualifications on a variety of facility and manufacturing process equipment and analytical testing equipment in a full Biotech upstream/downstream manufacturing plant.
- Qualification includes conception of qualification assessments, protocols, authoring protocols, execution, and final report writing.
- Facility equipment includes water, clean steam, clean compressed dry air, and nitrogen systems. Facility equipment also includes autoclaves, walk in controlled temperature units, environmentally controlled areas, process control systems, and building management systems.
- Manufacturing equipment includes a variety of lab equipment such as fermenters, process HPLC’s, analytical UPLC’s, and Spectrophotometers. Manufacturing equipment also includes label printing, and filling and packaging lines.
- Perform prequalification engineering studies to characterize equipment performance.
- Conceive, author, execute, and issue final reports on computerized software systems related to equipment.
- Excellent verbal communication and interpersonal skills required to interact with stakeholders such as system owners, quality assurance, and auditors.
- Excellent technical writing skills required. Studies, protocols, reports, deviations, and non-conformances must be written in a clear, structured manner directed to reviewers in an FDA regulated environment.
- Self-starter with the ability to work with minimal supervision in a fast paced environment. Ability to prioritize and manage multiple projects and priorities. Team player and willingness to help others and cross train as necessary.
- Proficient in Microsoft WORD, EXCEL, and POWERPOINT. Proficiency in Minitab statistical software and Track wise is a plus.
- (Required): Bachelor's Degree- in Biological/Life Sciences, Chemistry, Biochemistry or related field
- Equivalent combination of education and work experience.
- (Preferred) :
- ASQC Certified Quality Engineer is a plus
- ISPE Certified Pharmaceutical Industry Professional (CPIP) is a plus.
- Computerized Systems Validation experience a plus
- (Required): 2-5 years of experience
- (Preferred) : Experience in equipment, facility and/or critical utility qualification
Roche is an equal opportunity employer.Research & Development, Research & Development > Research