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Engineering Technical Lead

Employer
i-Pharm Consulting
Location
Amsterdam, North Holland, Netherlands
Salary
EUR110000 - EUR125000 per annum + +8.33% Holiday Allowance
Start date
25 May 2022
Closing date
8 Jun 2022

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Discipline
Manufacturing, Engineering
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

This role will be directly responsible for facilitating the project technical requirements for the TCF04 Phase 1b Expansion project and managing the design evolution process to execute and effectively turn over the project to Operations at project completion. The project duration extends through Q2 2023. The candidate should have experience in design and construction of GMP "clean room" manufacturing facilities. In addition, experience with Manufacturing Equipment Systems (MES) and Electronic Batch Record (EBR) implementation is a plus.
The ETL will monitor the technical/design deliverables for quality and scope. Additionally, the ETL will ensure that the design development process has the appropriate input from all stakeholders, users and Subject Matter Experts (SME's) to progress appropriately through the design process in a manner that is timely, efficient, thorough and effective.
Design - Programming/BOD/Conceptual/Basic/Detailed Design
* Ensure that the quality and completeness of the design deliverables is defined and met.
* Primary point of contact with the A/E design firm and with the internal stakeholders for technical/design issues.
* Ensure the programming through design completion effort is defined with clear goals/milestones.
* Ensure User/SME participation in the appropriate development work sessions.
* Utilising SME's, monitor progress for proper technical content.
* Provide technical information to the project as needed either via Guides/Standards and/or technical assessments to ensure the design follow standards and guides and meet the project goals/deliverables.
* Responsible for the execution of risk management mechanisms (Quality, Safety, Business Continuity) via the appropriate risk measurement tool (FMEA, HAZOP, PHA).
* Ensure technical/engineering deliverables are defined and developed commensurate with the design stages.
* Provide technical review of documentation including Engineering SOPs, Engineering drawings, functional test plans, User Requirements Specifications (URS), FATs and SATs
Pre-construction
* Support constructability reviews with the design team and Construction Manager.
* Ensure the BIM (Building Information Modeling) process is clearly defined and contracted (working with Drawing and Document Management team)
Construction
* Responsible for the initiation and execution of the Engineering Change Management (ECM) process, including approval of Engineering Change Notices (ECNs.).
* Ensure the proper review and response of Submittals and RFI's are executed by the A/E of record effectively and in accordance with the contract.
* Ensure identified scope gaps and scope additions are technically assessed in accordance with the ECM process.
* Utilising SME's, support the periodic review of field installations ensuring field work is performed in accordance with the contract documentation and specifications.
* Ensure the General and Sub-contractors have coordinated all field routing and meet the design and specifications for accessibility.
* Ensure a clear system-by-system definition of Mechanical Completion and systems are started up in accordance with design, vendor requirements and can be operated safely.
* Ensure the Transfer of Care and Custody (ToCC) of each system is defined and executed.
* Ensure the contractor field redlines are maintained through the construction duration.

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

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