Cache of job #13878040

Job Title

Cleaning Validation Engineer

Employer

Lotusworks

Location

Carlow

Description

About Us. A valued and trusted partner to the world’s leading companies. We are committed to service excellence through our talented people who are empowered to be innovative and best in class. Location. A beautiful county is the south east region of Ireland, with the River Barrow flowing through the town; Carlow is home to its renowned Institute of Technology. It’s a great base if you want to be out of the hustle and bustle of the city but easy to reach Wexford, Kilkenny, Wicklow, Kildare, Laois & Dublin. Your Job Purpose. Working with the LotusWorks team as a Cleaning Validation Engineer, you will be responsible for writing and reviewing cleaning verification, (re)validation and annual assessment protocols and reports, and ensuring these comply with global cleaning policies, procedures and guidelines and external regulatory requirements. Responsibilities. Authoring, Review and/or Oversight of cleaning validation-related procedures, protocols and technical reports required; Ensure Cleaning Validation Plans and strategies are in alignment with global policies, procedures and guidelines and external regulatory requirements; In partnership with Quality, Sub-System Owners and Technical Operations, develop cleaning re-validation programs, as appropriate; Participate on investigation teams in the event of adverse cleaning validation trends/failures to identify root cause and corrective/preventative actions. Expected to bring cleaning validation expertise and strong analytical and systematic problem solving skills; In collaboration with the QA, QC, Process Development and Transfer Teams, and Operations (IPT) support cleaning validation needs to meet regulatory expectations and supply timelines, including coordination of soiling studies; Write and review cleaning verification and validation protocols and reports; In collaboration with the Operations (IPT) and QA, support cleaning validation needs to meet regulatory expectations and supply; Write and review cleaning verification and validation protocols and reports; Assess process, equipment, utility and/or facility changes for cleaning validation impact; Organize, perform and report annual and baseline visual inspections of product contact equipment; Ensure timely execution of the visual inspections, in agreement with Manufacturing. Requirements. Academic degree in life sciences (Biotechnology or related) or comparable level through experience. At least 3 years of experience in biologics/pharmaceuticals manufacturing; Knowledge of GMP guidelines and global validation expectations; Strong project management skills & proven ability to manage complex projects; Customer focused, process oriented and data driven; Passion for Continuous Improvement; Benefits. Life Assurance. Pension Contribution. Training & Educational Assistance (Engineers Ireland CPD Members. Healthcare Contribution. Annual GP Check-Up. Extra Annual Leave. Healthcare Screening. Refer someone you know for this role and if we hire them you will receive a €250 voucher. (T’s & C’s apply) Click on the following link to Refer Your Friend today! http://www.lotusworks.com/en-ie/refer-a-friend. Not ready to apply, or have some questions? Call our Talent Specialist’s on +3537191-69783 or Email jobs@lotusworks.com and we will be happy to help! LotusWorks is proud to be listed in the Best workplaces 2017. Empowering talent we care about for over 29 years. LotusWorks is an Equal Opportunity Employer. This job originally appeared on RecruitIreland.com.

Date Added

2197 days ago

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