Aequor Technologies LLC Jobs (2)

Pharmaceutical Quality Engineer Senior Major responsibilities include but are not limited to : Perform Product and Process Trending, author reports and present at management review meetings. Perform trending of all environmental monitoring and process utility data author quarterly reports and escalate any issues or adverse trends to Senior Management. Calculate Contamination Recovery Rates (CRRs) for all Graded Manufacturing areas and personnel. Independently perform Quality Assurance walkthroughs of classified manufacturing areas to observe and evaluate production activities, aseptic processes and the proper execution of Batch Production steps, identify any deficiencies and escalate critical issue to Senior Management Lead the Alarm Reconciliation Program ensuring all facility Critical alarms generated are accounted for and proper root cause, corrective action, event assessment and trending is complete and accurate. Update Quality Assurance standard operating procedures as required Perform Gap assessments of corporate standards and guidance documents where required. Perform other Quality related tasks such as deviation investigations and GEMBA assessments when required Participate in programs for process improvements when required. Basic Qualifications : Bachelor's Degree and 5-10 years of relevant experience in Process trending and statistical control Preferred Qualifications : Ability to multitask. Ability to work independently Ability to interact and present information to upper level management Working knowledge of Word, Excel, Minitab, PowerPoint or other data management applications Ability to establish and maintain highly effective relationships with individuals from all levels of the organization.

Role is on-site Pay Rate - Strategy & Organizational Development : Ensures equipment operates to required HSE, Quality, Environmental and Reliability standards Lead or contribute to equipment, utility, facility improvement projects (e.g. energy efficiency, productivity, environmental compliance, maintenance) Support internal and external audits Implement GOPs If needed, create regional / site SOPs & templates Train operators and / or technicians Maintenance & Calibration : Execute maintenance improvement projects and initiatives (local or corporate) Lead and execute Decommissioning activities for the engineering team Establish cost efficient repair and maintenance processes in compliance with local regulations, HSE, GMP Establish / coordinate maintenance & calibration plan content Enter master data into CMMS (e.g. confirmation and technician time allocations) Coordinate maintenance / calibration activities Plan resources for maintenance / calibration Allocate work for maintenance / calibration to technicians Contribute to Master Instrument Inventory (MII) and Master Equipment Inventory (MEI) Enter work orders into CMMS for maintenance / calibration Develop method statement for maintenance / calibration Perform risk assessment for maintenance / calibration Provide frontline support for technicians Supervise maintenance / calibration work Assess quality impact and release after maintenance Assess equipment fit for purpose Set-up maintenance for new equipment (incl. spare part needs) Develop, monitor and improve KPI for maintenance & calibration Execute FMEA and define the maintenance type for each asset; assess equipment criticality (HML) Manage technical / engineering changes : originate Change Request, approve Change Request, close Change Request Investigate deviations (Root Cause Analysis) Create / maintain / verify engineering documents (protocols, drawings, lists, schedules, diagrams, layouts, calculations, datasheets) Plan spare parts (order spare parts, manage master data, minimum order quantity, documentation) Manage stores for spare parts (good receipt, incoming inspection, delivery to work area, make parts for quick repairs and improvements) Vendor & Contractor Management : Establish or contribute to vendor contract Project Engineering & Control : Identify technical solutions Prepare Equipment Specifications and System Requirements in project (e.g. User Requirement Specification) Prepare, review and approve drawings, lists, schedules, diagrams, layouts, calculations and datasheets in project Develop project turn over plan Perform new equipment FAT / SAT / inspections in project Perform commission activities Manage project deficiencies and deviations Perform provisional and final project handover Re-) Qualification : MODULAR Content for discipline SME Provide technical trouble shooting during PQ and validation Develop periodic requalification plan Execute periodic requalification plan