Commissioning (CQV) Engineer

3 weeks ago


Emory, United States CareerBuilder Full time

About NdIncorporated

Established in 2007, NdIncorporated is a patient-centric solution provider for the pharmaceutical industry. We specialize in engineering consultancy, commissioning, qualification and validation services, as well as regulatory quality and compliance in Asia and Europe. Our personalized solutions cater to the pharmaceutical industry's needs, focusing on engineering consultancy and regulatory quality and compliance. We are renowned for our value-adding commissioning, qualification, and validation services and expertise in developing the lean CQV methodology. Our offerings include GMP-certified software for environmental monitoring, contamination control, paperless validation, training, and professional recruitment services. At NdIncorporated, we prioritize patient safety, process understanding, regulatory compliance, and operational efficiency in safety, quality, delivery, and cost.

We are committed to delivering excellence every day, guided by our core values of empathy, integrity, and transparency. As an equal opportunity employer, we embrace diversity, promote inclusivity, and prohibit discrimination based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Responsibilities:

Lead and review project design documents (P&IDs, PFDs, URS, data sheets etc.)

Lead safety & design reviews (e.g. 3D model, HAZOP, and DQ)

Manage project and/or site change control

Lead a team to complete assigned tasks on time, on budget, and safely while adhering to quality and engineering standards

Vendor management

Participate in Quality Risk Assessment

Review and approve all technical documents

Provide input on project schedule

Track and report project status including cost status

Lead and coordinate all field work

Lead and manage commissioning and qualification activities

Overall responsibility for HSE matters in appointed area

Troubleshooting and resolution of Process related issues

Management of deficiencies and deviations

Ensure smooth hand-over to end user

Resource planning for assigned areas

Coordinate with other functions

Identify training matrix for the team

Requirements:

Degree in Engineering or Science Disciplines

Minimum 5 years experience in a related field/Pharmaceutical Industry

Proven track record in following and promoting Safety in all aspects of your role

Strong process and automation knowledge, adequate knowledge in utility and HVAC

Project management/coordination experience

Proactive and self-motivated

In-depth knowledge of cGMP, GDP, and ASTM E2500 approaches to C&Q

EA Reg. No: R2094147 | EA License No: 19C9587

Recommended Skills

3D Model

Automation

Certified Global Meeting Planner

Change Control

Coordinating

Field Studies

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