Commissioning and Qualification Lead

Full Job Description

About PSC Biotech

Who we are?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996,headquartered in Pomona, California, USA, with Global operations in Ireland,India, Singapore, Australia and the US, serving 350 clients in more than 23countries worldwide. We provide cloud-based software solutions for QualityManagement and Regulatory Inspections, pharmaceuticals contract manufacturingprofessionals, and metrology services to our clients.

‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by aligning our EVP asone of the unique selling point which includes the opportunity to work with themost talented cohort of like-minded professionals operating in the Pharma/ BiotechIndustry. We offer a permanent contract of employment giving exposure ofworking in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provide unparalleledempowering career development though Learning & Development in-housetraining mentorship through constant guidance to facilitate career progression.We believe in creating high performing teams that can exceed our client’sexpectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.

Responsibilities:

·      Manageteam of C&Q Engineers on high profile client site throughout the projectlifecycle.

·       Delta-Vexperience is desirable, running EM’s and CMs.

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·       Strongtrouble shooting experience

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·       Reviewand follow-up technical documentation from the early design phase in order toensure alignment with GMP and CQV requirements.

·       Investigateand resolve technical issues with assistance from engineers and/or suppliers.

·       Ensuresite project execution is undertaken in compliance with company guideline,department procedures and safety standards.

·       Befamiliar with the Mechanical Completion procedure and Construction scope ofwork (Walkdown, system acceptance, punch list and follow up).

·       Schedulepreparation and progress review.

·       Organizeand review daily activities of other CQV Engineers assigned to the project.

·       Projectmanagement principles to coordinate CQV activities and reporting to Company andClients PM.

·       Contractorsand Vendors management and coordination.

·       FinalHandover reports to the Client users

Experience,Knowledge and Skills:

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·       Delta-V experience is desirable

·       Project Management experience and certification desirable

·       Travelrequirement: Must bewilling to travel domestically (This requirement is estimated to be approximately20% of overall time).