Maulik Patel Email & Phone Number

Boston, MA, US

Hatboro, Pennsylvania, US

Spearheading the implementation of global OpEx program called “Kojo-X” for three facilities of globally leading CDMO which includes delivery of consistent standards, Unit Operations Classification, Risk Assessments, Design Qualification and C&Q plan for 40+ Unit Operations in Phase-1 of the project.

Waltham, Massachusetts, US

Create and maintain a comprehensive project plan that includes detailed Gantt charts, budget projections, and resource allocation. Ensure this plan is aligned with company strategy and R&D objectives.Lead cross-functional project teams and facilitate R&D meetings to establish project goals, drive execution, make timely decisions, identify and mitigate.

Hatboro, Pennsylvania, US

Effectively execute the business of Operations department that includes Engineering, Project Management, Facilities and Materials Management teams.Provide engineering leadership for the technology transfer efforts to implement new products at Azzur’s facility.Perform technical review of documents such as Tech Transfer Plans, Gap Analysis, Validation Master.

Hatboro, Pennsylvania, US

*Partnered closely with CMC functional areas to develop and maintained integrated project plans toidentify and communicate interdependencies as well as critical path activities for the project.*Effectively communicated with team members, senior leaders and key stakeholders on the status,objectives, critical paths, risks, and mitigation plans associated.

Hatboro, Pennsylvania, US

*Generate and execute FAT, SAT, IQ, OQ, PQ for equipment, systems, utilities and processes for qualification/verification and/or re-qualification/re-verification.* Generate user requirement specifications (URS), functional requirement specifications (FRS) & Detail Design Specifications (DDS)*Develop Validation Plans for validation projects, qualification.

Piscataway, New Jersey, US

* Review, update and generate process and utility P&IDs.* Prepare and maintain validation master plan and preventive maintenance program to keep all systems and equipment compliant with cGMP Standards.* Generated IQ, OQ and PQ protocols for Facility, Utility, System and Equipment which included fermenter, bioreactor, buffer tanks, autoclave, aseptic.

Bagsværd, DK

* Generated and executed IQ, OQ and PQ of facility, utility, system and equipment as part of periodic validation program.* Assisted in assessment of sampling plans and determined flow paths and sampling points which need to be tested in order to meet validation requirements. * Reviewed and walked down P&IDs to identify the modifications before protocol.

Durham, North Carolina, US

* Analyze and resolve complex issue associated with high –end real time diagnostic 3D workstations and 3D streaming service.* Test and Investigate problems related to real-time volume rendering hardware engines.* Maintain a detailed log of description of the issues and remedial actions taken in resolution of them.* Generate a report and follow-up with.

Bloomfield, CT, US

Performed field studies, tests, literature survey, designed and implemented a product to provide “cost- efficient” solution for IABP’s power supply unit issues working in a R&D team of Soma Technology.

Master Of Science (M.S.), Biomedical/Medical Engineering

Professional Education Program, Artificial Intelligence And Machine Learning

Bachelor'S Of Engineering In Biomedical Engineering, Biomedical/Medical Engineering