- Insmed Incorporated (NJ)
- …their lifecycle. You'll also:Lead the planning, execution, and documentation of computer system validation (CSV) activities for clinical applications.Collaborate ... in a biotech startup or high-growth clinical-stage company.Familiarity with computer system assurance (CSA) principles.Pay Range:$133,000.00-173,000.00 AnnualLife… more
- Twist BioScience (South San Francisco, CA)
- …maintain business process flows and training materials.QualificationsBachelor's degree in Information Systems , Computer Science, Business, or related field (or ... Staff System Business Analyst (Hybrid in South San Francisco...supporting our enterprise applications landscape, ensuring that our business systems seamlessly support our rapidly scaling biotech operations. As… more
- Insmed Incorporated (NJ)
- …Compliance, Legal, etc )Who You Are:Bachelor's degree in information technology, Computer Science, or related technical fieldMinimum 7+ years of experience in ... IT with focus on healthcare/pharmaceutical industryExperience with medical affairs processes and regulatory environmentsStrong technical knowledge of medical affairs applications and IT infrastructureProficiency in project management practices and agile… more
- Insmed Incorporated (NJ)
- …business, and IT infrastructurePrevious experience managing computer systems in pharmaceutical environmentsKnowledge of System Operational procedures ... IT System Owner for the Learning Management System and compliance IT systems , which includes...the requirements of the businessWho You Are:Bachelor's degree in Computer Science, Information Technology, or related field7+ years of… more
- Merck & Co. (Durham, NC)
- …above floor level. Walking, bending, crawling, and stooping is required.-Proficiency in computer systems and applications including but not limited to:- ... steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for providing quality oversight over the validation and qualification activities for equipment, systems , computer systems , and processes within a cell ... assessments, technical studies, and any associated documentation in support of computer systems validation, equipment, utilities, and facility qualification,… more
- Merck & Co. (Durham, NC)
- …above floor level. Walking, bending, crawling, and stooping is required.-Proficiency in computer systems and applications including but not limited to:- ... steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System … more
- Cipla (Fall River, MA)
- …documentation in a cGMP pharmaceutical operation environment. Technical Knowledge and Computer Systems Skills Understanding of machines used in pharmaceutical ... Participate in the internal and external audits to assure system control Review new batch manufacturing records, SOPs, APQR...the local and federal levels. Must be proficient in computer skills and software applications such as Microsoft Office… more
- ValSource, Inc. (Rahway, NJ)
- …process and cleaning validation is desirable. Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 ... with regulatory guidelines, client requirements, and company SOPs. Field Verifications and system walkdowns to confirm systems meet design and client… more
- Cipla (Fall River, MA)
- …validation documents. Preparation of qualification and validation documents of equipment and computer system . Preparation and qualification of e-batch record & ... candidates with experience in generic pharmaceutical manufacturing. Technical Knowledge and Computer Systems Skills Excellent communication skills, drive, and… more
