Commissioning Qualification Technical Lead

Flexible & Integrated Technical Services

Job Location:

Allendale County, SC - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

For Commissioning &Qualification support in the Engineering area.

WHAT MAKES YOU A FIT:
The Technical Part:

Bachelors Degree in Life Science or Engineering andpreviousyears of exposure in Validation Life Cycle and Packaging activities within the Pharmaceutical Industry.
Languages:English - fluent in speaking and writing.
Shift: Administrative and according to business needs.
Experience in:
Leadership and management roles.
Process Commissioning and Qualification.
Engineering disciplines commissioning compliance qualification and quality aspects of biopharma or pharmaceutical manufacturing.

The Personality Part:

Being self-motivated means that you are curious anxious to explore all possibilities without anyone telling you to (while also following instructions of course). It means youre creative with such an eye for detail that nothing gets past you. If this sounds like you and if you have a commitment to serving customers with high-quality research and products to embracing a diverse work culture and even to the environment you might just be what were looking for!

AS A PIECE OF FITS YOU WILL: (The day-to-day on the job)

Responsible for planning preparation coordination and leading a CQ team from documentation preparation through Design FAT CM oversight MC integrated CQ execution and successful handover to the Client USER team.
The CQ SME will lead and coordinate a CQV team that consists of CQV leads/specialists engineers operations personnel engineering and external vendors contractors sub-contractors including the automation integrator and CSV service provider.
Ensure that overall Budget Baseline Schedule Compliance Quality and HSE objectives are achieved in line with Project expectations. The CQ Lead will form part of the Client leadership team attending core team meetings providing guidance on CQ matters and representing PDP in terms or contractual obligations.
Development of an overall level 3 CQ plan in conjunction with the Client project and delivering key project milestones.
Lead various weekly multidisciplinary CQV Eng CM and USER coordination chart maintenance and resourcing.
HSE and Safe Start-Up including LOTO. CQV Doc Preparation. CQV Execution Readiness. CQV Execution. PID Walk down and Punch item Categorization.
Deviation Management & Change Control (Process and Automation). Punch List Management Vendor Management.
Developing and Reviewing CQ test plans and specifications prior to their approvals.
Development and maintenance of training material matrix and files for all those involved in CQV activities (Integrator CSV provider Vendors Client USERs).
Management and Filing of CQV related documentation.
Management: Compliance with a schedule at a system and area level with the planned resource levels.

WHO WE ARE:
We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our companys puzzle: you! We integrate Engineering Construction Maintenance Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible family-oriented and focused on our resources well-being while providing our Pharmaceutical Medical Device and Manufacturing industryclients with top-notch quality talent.Were FITS!

Are you the Next Piece

Required Experience:

Manager

For Commissioning &Qualification support in the Engineering area.WHAT MAKES YOU A FIT:The Technical Part:Bachelors Degree in Life Science or Engineering andpreviousyears of exposure in Validation Life Cycle and Packaging activities within the Pharmaceutical Industry. Languages:English - fluent in sp...

For Commissioning &Qualification support in the Engineering area.

WHAT MAKES YOU A FIT:
The Technical Part:

Bachelors Degree in Life Science or Engineering andpreviousyears of exposure in Validation Life Cycle and Packaging activities within the Pharmaceutical Industry.
Languages:English - fluent in speaking and writing.
Shift: Administrative and according to business needs.
Experience in:
Leadership and management roles.
Process Commissioning and Qualification.
Engineering disciplines commissioning compliance qualification and quality aspects of biopharma or pharmaceutical manufacturing.

The Personality Part:

Being self-motivated means that you are curious anxious to explore all possibilities without anyone telling you to (while also following instructions of course). It means youre creative with such an eye for detail that nothing gets past you. If this sounds like you and if you have a commitment to serving customers with high-quality research and products to embracing a diverse work culture and even to the environment you might just be what were looking for!

AS A PIECE OF FITS YOU WILL: (The day-to-day on the job)

Responsible for planning preparation coordination and leading a CQ team from documentation preparation through Design FAT CM oversight MC integrated CQ execution and successful handover to the Client USER team.
The CQ SME will lead and coordinate a CQV team that consists of CQV leads/specialists engineers operations personnel engineering and external vendors contractors sub-contractors including the automation integrator and CSV service provider.
Ensure that overall Budget Baseline Schedule Compliance Quality and HSE objectives are achieved in line with Project expectations. The CQ Lead will form part of the Client leadership team attending core team meetings providing guidance on CQ matters and representing PDP in terms or contractual obligations.
Development of an overall level 3 CQ plan in conjunction with the Client project and delivering key project milestones.
Lead various weekly multidisciplinary CQV Eng CM and USER coordination chart maintenance and resourcing.
HSE and Safe Start-Up including LOTO. CQV Doc Preparation. CQV Execution Readiness. CQV Execution. PID Walk down and Punch item Categorization.
Deviation Management & Change Control (Process and Automation). Punch List Management Vendor Management.
Developing and Reviewing CQ test plans and specifications prior to their approvals.
Development and maintenance of training material matrix and files for all those involved in CQV activities (Integrator CSV provider Vendors Client USERs).
Management and Filing of CQV related documentation.
Management: Compliance with a schedule at a system and area level with the planned resource levels.