Manufacturing Systems Test Engineer

We are #Hiring: #Manufacturing Systems Test Engineer

Job Title : #Manufacturing Systems Test Engineer

Location : BANGALORE - ( Hybrid )

Total Yrs. of Experience : 5 to 8 Years

️ Duration: Contract to Hire (C2H)

Notice Period: Immediate Joiners to 30 Days

Job description*:

Overall Objectives of the Position

The “Manufacturing Systems Test Engineer” plays a crucial role in ensuring the quality and efficiency of manufacturing processes through Electronic Batch Records (MES/EBR) and Data Historian (DH) systems.

- Collaborate with the IT team, system owners, vendors, and business stakeholders to coordinate Specifications (URS).

- Author or co-author specifications (Functional Specifications (FS), Design Specifications (DS), Configuration Specifications (CS), and Technical Specifications (TS) for EBR and DH systems.

- Author or co-author including Operational Qualification (OQ), Performance Qualification (PQ), and User Acceptance Testing (UAT) protocol/scripts to ensure systems meet specified requirements and specifications.

- On demand, perform or support OQ testing as per approved protocols. Support business in the execution of PQ and UAT.

#Responsibilities:

Computerized System Validation (CSV)

- Design, configure, and release Master Batch Records (MBRs) and workflows for MES and Data Historian systems, demonstrating expertise in these areas.

- Utilize in-depth knowledge to configure equipment using Aveva PI Data Historian.

- Effectively collaborate in a global environment and with international teams.

- Conduct validation testing activities for DH and Manufacturing Equipment System (Pas-X MES) per FDA regulations, GAMP guidelines, and Merck's internal validation procedures.

- Develop and execute test protocols (OQ and PQ) for DH and MES systems, ensuring comprehensive coverage of functional and performance requirements.

- Perform risk assessments and impact analyses to identify potential validation issues and establish robust testing strategies.

- Collaborate closely with cross-functional teams (IT, Quality Assurance, Manufacturing, Validation and Engineering) to coordinate validation activities and address issues.

#Mandatory skills:

Werum PAS-X

#Desired/ Secondary skills:

Werum PAS-X, MES, IOT

#Domain:

Pharma/Life sciences

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Thanks & Regards

P. Sona

Talent Acquisition

Burgeon IT Services Pvt.ltd.

Email : ,

Website:www.burgeonits.com

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