On-Site Engineering Coordinator

ROSY PEGU-D’SOUZA

Address: **** ****** **, *******, ** 94536

Cell: 510-***-****

Email Address: *******@*****.***

Facilities and Equipment Engineering Coordinator

Minaris Advanced Therapies· Full-time (May 2023 - Present) On-site

1)Plan, direct and coordinate operations, and functionalities of 1031 instruments (Calibration, PM, troubleshooting and repairs) and the facility (HVAC, Electrical, Controls, Plumbing, Pests Control, and General Maintenance). Giving access, accompanying and monitoring the technicians and FSEs during their activities.

2)Monitor ViewLinc. of 137 Vaisala probes and responding to alarms for accurate functionality of the assets and maintenance of required environment in labs.

3)Familiar with the blueprint of the facility, badge access and security systems (sensors, control panels, cameras and alarms).

4) Maintain contract agreements with multiple vendors (35+); reviewing them on a regular basis. Financial management (financial tracking, budgeting and forecasting).

5)Projects involved: PCR room blueprint design using AutoCAD and equipment purchasing and set up, Boiler and Chiller replacement, Facility revitalization, closing multiple CAPA.

6)VHP decontamination of the clean rooms for ICRA; decontamination of equipment (used for processing products) and HEPA filter certification and Air Balance maintenance to prevent HCAI.

7)Familiarity with cGMP, FDA OSHA and required regulatory requirements.

8) Update maintenance-related data of the instruments and works performed in the CMMS software. Experienced with Microsoft excel, Smart sheet and VLOOKUP.

9)Understands SOPs, maintenance operations, and machinery operating procedures; initiate NOE, deviation, change control process and CAPA.

10) Works with Reliability Engineer by monitoring and analyzing Project works, and to optimize effective and efficient PM procedures, planning, and scheduling.

Equipment Engineering Coordinator

GRAIL · Contract (Jun 2022 - Feb2023) On-site

1.Completed a project on OOT assets/ NCR (2021-2022) using Asana, tableau.

2.Write and perform annual review of standard operating procedures.

3.Assist with training of new laboratory personnel and training of new procedures with existing personnel.

4.Proofreading EMERF, equipment OOT forms, NCR, ERAS and vendors’ calibration and Preventative Maintenance certificates); make sure the PMs and Calibration of assets are performed in accordance with the ISO9001 and also following company SOPs; approving documents, routing for review and responsible for their transfer and storage.

5. Maintain and track information related to equipment and service dates on relevant dashboards.

6.Act as liaison with multiple laboratories regarding service and calibration events; coordinate and maintain ISO9001 Quality Management Systems (QMS).

7.Labeling kits and equipment; support equipment life cycle management and updates as required in BMRAM CMMS system/ LIMS.

8.Utilize computerized maintenance management system (CMMS) for PO, to schedule and track all OE on demand and scheduled work.

9. Coordinate with external equipment vendors for on-site report of contracted equipment.

10. Manage renewal of equipment service contracts to maintain continuous coverage.

11)Maintain inventory of spare parts, consumables, and equipment for performance of duties related Operations Engineering routine activities.

Clinical Lab Associate

Lucence Contract (APR2022-JUN2022) On-Site

1)Plasma extraction and accessioning specimens into the laboratory information management system (LIMS); tracking delivery, receiving and checking patient specimens against order forms.

2)Performing routine laboratory maintenance tasks: preparing and stocking reagents, arranging and cleaning work benches, fume hoods, BSC, pipettes and stocking other consumables; instrument calibration and maintenance, removing biohazard trash bags. Maintaining logbooks for each of the activities. Check-out from the lab at the end of the day.

3)Kit making and labelling.

4)Participating in quality control and quality assurance activities.

5)Maintaining adequate level of supplies for the laboratory. Tasks included ordering, receiving, unpacking, documentation and labelling of consumables and reagents.

6)Proofreading batch records, logbooks, order receipts, sample forms after accessioning and extraction.

cGMP Specialist

CSBio · Full-time (Jun 2019 – Jun 2020) On-Site

1)Plasma extraction and accessioning specimens into the laboratory information management system (LIMS); tracking delivery, receiving, and checking patient specimens against order forms.

2)Performing routine laboratory maintenance tasks: preparing and stocking reagents, arranging, and cleaning work benches, fume hoods, BSC, pipettes and stocking other consumables; instrument calibration and maintenance, removing biohazard trash bags. Maintaining logbooks for each of the activities. Check-out from the lab at the end of the day.

3)Kit making and labelling.

4)Participating in quality control and quality assurance activities.

5)Maintaining adequate level of supplies for the laboratory. Tasks included ordering, receiving, unpacking, documentation and labelling of consumables and reagents.

6)Proofreading batch records, logbooks, order receipts, sample forms after accessioning and extraction.

Education:

Certified Clinical Research Professional Society (CCRPS)

ACCRE Accredited Advanced Clinical Research Associate Certification (MAY2022)

Ohlone College

Psychology Associate Course (Fall Semester, 2021)

American Medical Writers’ Association (AMWA)

Certificate Program, Regulatory and Research (2018)

Gauhati Medical College and Hospital

Doctor of Medicine, MD (JUN2010)

Silchar Medical College and Hospital

Bachelor of Medicine and Surgery, MBBS (MAY2005)

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