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Snr CQV Engineer

5599D

Senior CQV Engineer required for Pharmaceutical client

Category:
Validation
Location:
Leinster
Years of Experience Req.:
4 Years+
Date Posted:
21/08/2019
Days Remaining:
29
Employment Type:
Contract
Education Level Req.:
Bachelor Degree

Senior CQV Engineer

DPS is a leading Project Management and Engineering Company serving industry around the world for over 40 years. Our reputation is based on forming successful partnerships with our clients, providing them with innovative designs and cost effective solutions in the context of sound judgment, strong management and technical excellence. We employ over 600 people out of our six office locations and serve a broad range of clients ranging from multinational companies to small generic producers.  We provide Full Service Engineering for our clients including Project and Programme Management, Procurement, Design, Construction Management, Health & Safety Management, Commissioning, Qualification, Professional Outsourcing and Start-up on global projects across a range of market sectors.

Senior CQV Engineer

DPS Engineering currently have an opportunity for a CQV Engineer with a South East based Pharmaceutical client. 

Responsibilities

Write, review, approve and execute commissioning and qualification documents (equipment and facility)

Plan validation project schedules and prioritiz720476.739493e validation activities in line with schedules and overall technology transfer priorities

Attend and sign-off on equipment FATs

Attend and sign-off on construction walk downs

Manage the vendor representatives in the field during commissioning/qualification

Managing the preparation of equipment test runs

Execution of testing and the SAT/IOQ documents onsite

Complete review of vendor & construction docs to support commissioning and qualification activities

Ensure non-conformances and deviations are minimised and closed out in a timely manner

Attend project meetings with senior management and report progress

Supervision of contractors/vendors during commissioning

Preparation of commissioning and qualification summary reports

Manage commissioning and qualification of equipment and facility

Identify and implement system optimisations where required

Provide technical input during investigations, gap analysis, risk assessment and change control process

Provide validation related support to all departments

Requirements

Bachelor of Engineering or Science Degree in Engineering or related discipline

Minimum of 10 years’ experience in the Pharmaceutical Industry in a validation role

Experience working in a solid oral dose environment

Experience in preparation & sign off of SAT and qualification (IO/OQ) documentation

Experience in managing commissioning and qualification projects

Experience of both equipment and facility qualification

Excellent attention to detail and good documentation practices

Ability to understand project plans and schedules

Strong written and oral communication skills

Strong knowledge of GxP

Process validation experience (including protocol write up and execution).

Process scale-up and optimiz720476.739493ation for manufacture of clinical and commercial products.

Experience in technical transfer of specified unit operations to contract manufacturers and supporting external process scale-up activities.

Computer systems validation experience

To discuss this role in further detail contact Shane Whyte on 01 466 1724. 

DPS Engineering is an Equal Opportunities Employer.

Recruitment Agencies: Please do not reply to this job advert.

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