- Insmed Incorporated (San Diego, CA)
- …hands-on experience in a validation role with responsibility for computer systems specifically LIMS, eTMF/CTMS, and other Clinical/Manufacturing systems ... Manage and provide oversight on multiple projects simultaneously. Coordinate and lead validation activities with internal stakeholders and project team… more
- Cipla (Fall River, MA)
- …documents. Preparation of qualification and validation documents of equipment and computer system . Preparation and qualification of e-batch record & e-Log ... Job Title : Mfg. Validation Engineer FLSA Classification : Professional, Exempt Work...with experience in generic pharmaceutical manufacturing. Technical Knowledge and Computer Systems Skills Excellent communication skills, drive,… more
- Syner-G BioPharma Group (Boston, MA)
- …production systems , with a concentration on computerized equipment and systems validation .Report writing experience for IQ, OQ, PQ, and CSV.Knowledge, ... systems for compliance with manufacturing requirements and facility fit. Lead start-up activities, including commissioning and qualification of facilities,… more
- Cipla (Hauppauge, NY)
- …(DPI, MDI, oral solid or Injectables preferred). Technical Knowledge and Computer Systems Skills Effective interpersonal relationship skills and the ... to departmental SOPs, periodic review and reporting of the environmental monitoring system . Generate, review, approve and maintain Validation Master Plan and… more
- Merck & Co. (Rahway, NJ)
- …development programs ranging from concept generation/selection, development, verification, and validation to launch readiness: Lead the cross-functional Device ... Job DescriptionAssociate Principal Scientist - Device Technical and Engineering Lead (Associate Director Equivalent) Our company's Device Product & Process… more
- ValSource, Inc. (Rahway, NJ)
- …and cleaning validation is desirable. Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 ... other regulatory requirements. ResponsibilitiesOn-Site Project Management: Interface with clients, lead teams of validation professionals, and provide subject… more
- Insmed Incorporated (NJ)
- …years' experience in a management validation role with responsibility for computer systems specifically eTMF, CTMS, EDC, IRT, eCOA/ePRO and other ... Clinical/Manufacturing systems .Minimum of a Bachelor's Degree in Computer Sciences, Engineering, or related fieldProject lead experience preferred.Strong… more
- Cipla (Fall River, MA)
- …and CQA for preparation and implementation of SOP'S (Case Basis) IT for computerised system validation (Case Basis) Central SCADA Team for Real time process ... documentation in a cGMP pharmaceutical operation environment. Technical Knowledge and Computer Systems Skills Understanding of machines used in pharmaceutical… more
- Cipla (Fall River, MA)
- …AM - 5:00 PM (May vary based on business needs) Reports To : QA QMS Lead Salary Range : $64,272 - $77,662 PURPOSE The QA Document Control Associate in a ... ICH, and ISO. This role supports the Quality Management System (QMS) by maintaining accurate, secure, and accessible documentation...Quality Team. The position reports to the QA QMS Lead and may be matrixed to other functional leaders… more
- Merck & Co. (Rahway, NJ)
- …Validation plans and annual reports supporting equipment, critical utilities, and computer systems .- - Demonstrate knowledge of equipment operation to support ... Project Manager (PM) role, SAP Plant Maintenance eVal- - Paperless electronic validation system Experience with ProCal as a Computerized Calibration Maintenance… more
- Cipla (Fall River, MA)
- …Manufacturing Practices (GMP)/Good Distribution Practices (GDP), etc. Technical Knowledge and Computer Systems Skills Understanding of machines used in ... Quality Team. The QA operation specialist (MDI) monitors and ensures validation and qualification of facility, utilities, equipment's, processes and ensure product… more
- Aptyx (Charlotte, NC)
- …process for projects Develop feasibility and reliability testing plans for catheter systems , including the development and validation of accurate in-vitro and ... The primary role of an R&D Engineer is to lead project deliverables and lead technical reporting...conclusions. DUTIES AND RESPONSIBILITIES Responsible for following the Quality system , including all applicable SOPs included in the Training… more
- Insmed Incorporated (NJ)
- …seeking an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will ... landscape and protect sensitive patient and research data.Demonstrated experience leading a Computer Systems Validation team in a regulated (pharmaceutical,… more
- Formation Bio (New York, NY)
- …Practices (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation (CSV).The primary responsibilities for ... there is a substantial component of oversight for the computer systems validation . The implementation...and external teams to implement corrective and preventive actions. Lead the quality review process, ensuring the effective review… more
- Cipla (Fall River, MA)
- …candidates with experience in generic pharmaceutical manufacturing. Technical Knowledge and Computer Systems Skills Excellent communication skills, drive, and ... of approved procedures. Develop strategies and documents for cleaning and process validation of equipment and products in compliance with site SOPs and regulatory… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …have experience working within an aseptic manufacturing facility, preferably in training/ system applications, quality systems , or learning management systems ... training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation , Technical Support, Supply Chain) that supports daily clinical… more
- Cipla (Hauppauge, NY)
- …dispensing process. To perform posting of dispensed materials and samples into SAP system and to perform other transactions in SAP. Maintenance of standard weights ... manufacturing record instructions. Collection of in-process blend, finished product, validation samples for analysis, sample collection as per protocols.… more
- Endo International (St. Louis, MO)
- …and review. The position will also have responsibilities for the review/approval of validation activities for enterprise computer system software and other ... serve live their best life. **Job Description Summary** The Lead Validation Engineer will create, review and/or...at other sites involved with enterprise computer system software, Data Integrity, and equipment/process validation … more
- International (Elmendorf, TX)
- …products and solutions to our customers. The Senior Engineer - HVAC, Testing and Validation will lead and execute testing activities focused on the performance, ... plans and create innovative test procedures tailored to HVAC and cooling system evaluations + Execute validation activities according to engineering standards… more
- Curia (Albany, NY)
- … Engineer will be responsible for supporting Quality Management Systems and Computer System Validation efforts. This role will provide guidance and ... matching contributions + Learning platform + And more! Responsibilities Computer Systems Validation + Manage...stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation… more
