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Senior Validation Engineer

Employer
i-Pharm Consulting
Location
Dublin, Republic of Ireland
Salary
EUR60 - EUR64 per hour
Start date
21 Mar 2023
Closing date
4 Apr 2023

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

Job Details


The activities of the Senior Validation Engineer are to:
o Provide expert technical validation support to meet site objectives, comprising of the full validation lifecycles process across a varied equipment portfolio.
o Development, review and approval of Validation Plans, QRAES, URS, IV/FTs, SATs, Cycle development and PQs etc. for process equipment in line with GMPs, regulatory requirements, and company standards.
o Liaise with engineering, commissioning and qualification personnel, and external vendors regarding equipment qualification and cycle development best practices ensuring quality by design principles are being followed.
o Manage and execute the equipment validation cycle development, performance qualifications and requalification program in line with projects and site validation masterplans.
o Collate and report on relevant validation data and metrics.
o Assist in the development and improvements of the equipment validation and sterilisation lifecycle process while ensuring continued compliance to all applicable regulations and company standards. In addition, provide input and guidance into multisite and local procedural requirements.
o Coordinate projects and prioritize workload in line with site priorities.
o Participate, when required, as a member of multidisciplinary site and multisite teams, e.g. cross functional investigation teams, Validation and C&Q network and ISPE network discussions to influence industry best practices.
o Update and maintain validation Standard Operating Procedures (SOPs) in accordance with site and corporate requirements.
o Participate in regulatory inspections, regulatory filings and RTQs
o Attend and contribute to staff meetings and attend appropriate training sessions, as required.
o Comply with the responsibilities as outlined in the Site Safety Statement and champion safe working practices and initiatives within their functional area.
o Perform validation activities using a paperless validation system and identifying opportunities for improvement
Basic Qualifications:
o Bachelor of Science/Engineering degree or equivalent.
o Knowledge of cGMPs and other worldwide regulatory requirements.
o Problem solving ability and excellent oral and written communications skills
o 5+ years' experience in a similar role
Preferred Experience:
o In depth experience in equipment qualification and the validation lifecycle process in line with ASTM E2500.
o In depth experience qualifying filling systems within the sterile manufacturing environment of drug product.
o Previous experience in regulatory inspections.
o Independent, self-motivated, proactive, organized, able to multi-task in project environments and skilled in communication and collaboration.
o Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

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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