interpersonal skills that allow them to collaborate well with various
individuals, groups and departments, in addition to a technical
foundation.
The successful candidate must have upfront development of the C&Q
strategy, Initially, this role will cover the front-end aspects as
well as hands-on capability later in project.
This project is expected to run until the end of **Apply on the
website**
Responsibilities:
1. Lead and coordinate commissioning and qualification activities on a
biologics expansion project incorporating utilities, Labs and process
equipment. Ensure compliance with HPRA, MHRA, FDA and cGMP
requirements
2. Plan and track activities and liaise with the various stakeholders
on the commissioning team and the overall project. Provide technical
process support to the commissioning team throughout the project life
cycle. Participation in HAZOP and design reviews. Oversee the
generation, execution and approval of Commissioning & Qualification
documentation.
3. Management of vendor engineers and contractors during C&Q
activities;
4. Ensure that handover from construction to commissioning is properly
defined, documented and in line with project requirements ensuring
handover packages are reviewed and complete.
5. Ensure that C&Q activities are scheduled, budgeted and resourced in
line with the project delivery requirements. Ensure sequencing of
handover of systems is properly aligned with the project requirements.
Develop, agree and provide all required training
BASIC QUALIFICATIONS:
1. Third level degree in a relevant discipline;
Proven level of experience in delivering Commissioning, Qualification
& Validation (CQV) activities within the biotechnology sector
including developing all required Project Validation Plans, Master
Plans, System Lists, Commissioning Procedures etc
2. At least **Apply on the website** years of experience in a cGMP
manufacturing environment with minimum of 5 years in a lead role.
3. A proven track record of leading commissioning and qualification
activities of complex projects and developing cross-functional
initiatives.
4. In-depth understanding of large scale biotechnology unit
operations, principles of biochemical engineering, and process data
analysis;
5. Strives for results and sets ambitious tangible and measurable
targets; takes personal responsibility for achieving results; reviews
and evaluates progress against agreed targets, timelines and budgets;
6. Strong knowledge and experience in GMP environment and working
within Quality System;
7. Strong knowledge and experience in project management, ASME BPE,
and ISPE guidelines;
8. Good knowledge and experience in EHS;
9. Self-motivated with minimum management and Good communications
skill;
**Apply on the website**. Fluent in written and verbal English
communication.
PREFERRED QUALIFICATIONS:
1. Proven leadership capabilities in a prior role;
2. Able to engage and align other stakeholders outside the project
team;
3. Ability to understand and communicate risks and develop and execute
contingency plans;
4. Extensive experience in the operation of large scale biotechnology
processes;
5. Hands on experience with large scale biotechnology unit operations;
6. Bio-process manufacturing experience is highly desirable;
7. Proven ability to lead cross-functional and technical teams and
align, motivate and empower team members CQV Lead candidate must be a highly motivated leader with solid
interpersonal skills that allow them to collaborate well with various
individuals, groups and departments, in addition to a technical
foundation.
The successful candidate must have upfront development of the C&Q
strategy, Initially, this role will cover the front-end aspects as
well as hands-on capability later in project.
This project is expected to run until the end of **Apply on the
website**
Responsibilities:
1. Lead and coordinate commissioning and qualification activities on a
biologics expansion project incorporating utilities, Labs and process
equipment. Ensure compliance with HPRA, MHRA, FDA and cGMP
requirements
2. Plan and track activities and liaise with the various stakeholders
on the commissioning team and the overall project. Provide technical
process support to the commissioning team throughout the project life
cycle. Participation in HAZOP and design reviews. Oversee the
generation, execution and approval of Commissioning & Qualification
documentation.
3. Management of vendor engineers and contractors during C&Q
activities;
4. Ensure that handover from construction to commissioning is properly
defined, documented and in line with project requirements ensuring
handover packages are reviewed and complete.
5. Ensure that C&Q activities are scheduled, budgeted and resourced in
line with the project delivery requirements. Ensure sequencing of
handover of systems is properly aligned with the project requirements.
Develop, agree and provide all required training
BASIC QUALIFICATIONS:
1. Third level degree in a relevant discipline;
Proven level of experience in delivering Commissioning, Qualification
& Validation (CQV) activities within the biotechnology sector
including developing all required Project Validation Plans, Master
Plans, System Lists, Commissioning Procedures etc
2. At least **Apply on the website** years of experience in a cGMP
manufacturing environment with minimum of 5 years in a lead role.
3. A proven track record of leading commissioning and qualification
activities of complex projects and developing cross-functional
initiatives.
4. In-depth understanding of large scale biotechnology unit
operations, principles of biochemical engineering, and process data
analysis;
5. Strives for results and sets ambitious tangible and measurable
targets; takes personal responsibility for achieving results; reviews
and evaluates progress against agreed targets, timelines and budgets;
6. Strong knowledge and experience in GMP environment and working
within Quality System;
7. Strong knowledge and experience in project management, ASME BPE,
and ISPE guidelines;
8. Good knowledge and experience in EHS;
9. Self-motivated with minimum management and Good communications
skill;
**Apply on the website**. Fluent in written and verbal English
communication.
PREFERRED QUALIFICATIONS:
1. Proven leadership capabilities in a prior role;
2. Able to engage and align other stakeholders outside the project
team;
3. Ability to understand and communicate risks and develop and execute
contingency plans;
4. Extensive experience in the operation of large scale biotechnology
processes;
5. Hands on experience with large scale biotechnology unit operations;
6. Bio-process manufacturing experience is highly desirable;
7. Proven ability to lead cross-functional and technical teams and
align, motivate and empower team members
We need : English (Good)
Type: Permanent
Payment:
Category: Others
