operations, engineering or any combination thereof.
If you have the relevant experience, please forward your CV to **Apply
on the website** for review or call * **Apply
on the website** to discuss in confidence.
CQV ENGINEER - LIMERICK
JOB DESCRIPTION
Our client are involved in the Commissioning, Validation & Temperature
mapping activities on numerous Biotech sites.
Effectively working within a multidisciplinary team to Prepare,
schedule and execute Commissioning, Qualification and Validation
protocols
Lead Risk assessments for process and equipment as required.
Develop system impact assessments, validation plans, protocols and
reports that support the qualification and validation of systems.
Execute Commissioning and validation of manufacturing equipment,
downstream equipment and processes in addition to supervising and
witnessing Validation / Qualification carried out by vendors.
Develop protocols for validation projects using a risk based approach
that meets regulatory requirements and industry practices.
Review and approve Layout development and review for material and
personnel flow compliance.
Review analyze and interpret system performance data for completed
validation and prepare final report packages by summarizing the data.
Investigate deviations, write investigation reports and create summary
reports.
Manage equipment vendors to get vendor qualifications scheduled and
executed.
Promote cGMP and regulatory compliance into assigned projects.
Exercise good judgment within generally defined practices and policies
in selecting methods and techniques for obtaining solutions.
Strong trouble shooting and Safety compliance experience is essential
for this role.
Comprehensive practical and theoretical understanding of a wide range
of industrial plant and cleanroom services and utility equipment.
Proven experience in commissioning plant and equipment in a GMP
environment
Problem Solving - Identifies and resolves problems in a timely manner;
gathers and analyses information skillfully; develops alternative
solutions; works well in group problem solving situations; uses reason
even when dealing with emotional topics.
Leadership - exhibits confidence in self and others; inspires and
motivates others to perform well; effectively influences actions and
opinions of others; accepts feedback from others; gives appropriate
recognition to others.
Motivation - sets and achieves challenging goals; demonstrates
persistence and overcomes obstacles; measures self against standard of
excellence;
Planning/Organizing - prioritizes and plans work activities; uses time
efficiently; plans for additional resources; sets goals and
objectives; organizes or schedules other people and their tasks;
develops realistic action plans.
Professionalism - approaches others in a tactful manner; reacts well
under pressure; treats others with respect and consideration
regardless of their status or position; accepts responsibility for own
actions; follows through on commitments.
Quality Management - looks for ways to improve and promote quality;
demonstrates accuracy and thoroughness.
Innovation - displays original thinking and creativity; meets
challenges with resourcefulness; generates suggestions for improving
work; develops innovative approaches and ideas.
Communication - verbally communicates clearly and persuasively;
listens and seeks clarification when needed; good presentation skills;
participates effectively in meetings.
Writes clearly and informatively; varies writing style to meet needs;
presents numerical data effectively; able to read and decipher written
information.
REQUIREMENTS
BSc/MSc or BEng/MEng in Engineering or related discipline.
* years minimum in validation, quality systems,
operations, engineering or any combination thereof.
Experience in multiple GMP validation disciplines (process equipment,
utility, automation, computer systems, sterilization) with advanced
technical knowledge.
Validation experience using risk based approach guidelines,
international regulatory requirements and standards and other in.
Experience interacting with or creating material for representatives
of regulatory agencies and executive level staff.
Experience with investigations into manufacturing deviations and
determination of product impact potential, root cause and corrective
actions.
PACKAGE
Negotiable
We need : English (Good)
Type: Permanent
Payment: Negotiable
Category: Construction
