Senior Ait Quality Engineer

Year    Bangalore, Karnataka, India

Job Description


Make your TALENT count at NNE
We are experts in end-to-end pharma engineering and our success is built on our relationships, both with our colleagues and our customers. If you want to work on projects shaping the future of sustainable and intelligent pharma facilities, NNE is the place to be.Work with usWe are looking for a determined and dedicated Advanced Engineer for Process Automation who can provide innovative solutions in complete life science and pharmaceutical projects. This also includes understanding the client's complex process facilities, with Good Automated Manufacturing Practice (GAMP) regulated requirements for a pharmaceutical production facility. Our department consists of dedicated engineers, specialized in different phases of the project including Conceptual Design, Basic Design, Detailed Design, Commissioning and Qualification.Experience: Minimum 8+ years
Job function: PQM /AIT Quality - Senior Professional
Employment type: NNE employee
Department: Process AutomationHow you might spend your daysAs Senior AIT Quality Engineer, you'll be working with a motivated, multi-functional team where you'll be:
Responsible for deliverables where output is Medium to Complex in a specific area such as:
Leading or Supporting on Quality management/ validation activities for AIT, handling a team size of 5-6 people.
Supporting Sr. Project Quality Manager / Work Package Owner on defining quality scope in project, structuring, planning, giving input to cost calculations and proposals for quality work package.
Leading or guiding team on Protocol/ test plan preparation, Q reviews, defect handling & oversight (TIMS)
Preparing and Facilitating design reviews (DERs) & Document control (reports)
Preparing and Updating Quality documents such as QAP, SQP, VMP, PQMP.
Preparing / reviewing Operational Verification strategy (OV)
Preparing / reviewing Software design specifications (SDS) & Traceability matrix (RTM, DTM)
Conducting / participating in risk assessment.
Strong knowledge on SCC handling, impact assessment & closure action.
Good overview / knowledge on different systems (DCS, ECS, PI, PAS X, SGS)
Ensuring coordination across cross-disciplines and compliance with codes, regulations and procedures.
Ensuring project's validation (GMP, GEP) concepts are shared with team and are revisited on a regular basis.
Providing Coaching /Mentoring for Juniors with on- the -job training.
Act as Subject matter Expert in own discipline or Responsible for arriving at solution within/across teams.We offer you a position where you will interact with highly skilled engineers within Automation in an active and exciting environment that allows you to continue growing with new ways of working at NNE. You will work in a project-oriented, international climate supporting our customers and colleagues across the globe. Our projects cover the full range from small revamp projects to high-volume greenfield production facilities. NNE handles projects for a vast number of international customers and intends to continue expanding our business abroad. Consequently, you may expect travelling activities of shorter or longer duration.
We are ready to welcome our new colleague(s) with a professional onboarding program and internal courses and training that keep our biggest asset - you - developed for the long run.Who you are
At NNE, we care about who you are as a person. In the end, how you work, and your energy is what impacts the work we do as a team. As a person, you are:
Able to perform work independently.
Able to adapt procedures, processes, tools, equipment, or techniques to accomplish the correct output of specific assigned tasks.
Able to take initiative, prioritize, and plan the work to reach deadlines.
Having a positive approach and can be persistent when facing challenges.
Customer-oriented and focused with strong professional ethics.
Excellent in communication skills and open-minded to learn new things.
The miles you've walked.
To apply for the position there are some things that are needed, and others are a bonus. We believe these qualifications are needed for you to do well in this role:
Have a degree in engineering in Electronics/Instrumentation/ Electrical/Industrial Automation or similar technical field.
You have at least a minimum experience of 8 years in a similar field
Good working knowledge of 21CFR Part 11, GMP, GDocP, GAMP, risk assessment, change management and Quality documentation is preferred.
Experience in Integration Specs, Installation packages, Test and Qualification protocols including test plans would be preferable.
FAT, SAT, IQ and OQ experience would be preferable.Together we shape the future of pharma engineering.
Think of how it would be going to work every day to help pharma manufacturers establish efficient, sustainable and intelligent facilities that are essential for drug production worldwide. This is NNE. We are born and raised within pharma, which makes us more than a consultant engineering company. And if you share our values of innovating, taking initiative, and believing in teamwork, we invite you to join the passion!Sounds like something you'd like to do ? If you're ready to unleash your potential, let's have a talk.Deadline of application is 6th March 2025. We will invite to interviews on a running basis.Questions before applying? Please contact Akshatha on AZXY@nne.comPlease note we only accept applications submitted through our online recruitment system.At NNE, we commit to an inclusive recruitment process and equality of opportunity for all our job applicants.To learn more about us visit www.nne.com

NNE

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Job Detail

  • Job Id
    JD3601975
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Bangalore, Karnataka, India
  • Education
    Not mentioned
  • Experience
    Year