P
OS
I
TI
O
N
S
UM
M
A
R
Y
:
The
CQV Engineer II
is
responsible for supporting and ensuring systems, facilities, and equipment meet
the design requirements to be put in place for a facility.
The incumbent is
also responsible and accountable for the execution of the PSC mission, "to
maintain the integrity and professionalism of our products and services while
enabling steady growth and development.
"
D
U
T
I
E
S
A
N
D
R
ES
P
ONSIBI
L
IT
IE
S
:
·
To
work alongside the client team's in in commissioning and qualification
activities that align with the project objectives
·
Support to commission, qualify, and validate facilities,
utilities, and/or equipment in assigned projects.
·
Initiates, authors, revises, reviews, and completes
controlled documents for CQV projects.
·
Writes and reviews GMP and GDP documents and
technical specifications.
·
Collaborate with multiple departments on
assigned project activities and deliverables.
·
Initiate and coordinate risk analyses, design
reviews, execute FAT/SAT, IQ, OQ, and PQ.
·
Supports development SOPs and review final reports.
·
Contact and work with contractors and vendors
on assigned projects.
·
Mentoring and providing consultation to the
client and local team.
·
Responsible for managing project activities
and timelines.
·
Provided status reports of projects to the PSC
Project Manager.
·
Ability to travel as needed.
·
Additional
duties and responsibilities may be assigned from time-to-time.
DE
M
O
N
S
TR
A
T
E
D
C
O
M
P
E
T
E
N
CI
ES
:
·
Relationship
Building
– Works with and across formal and informal
skilled and social networks to build long-term partnerships and
connections in the life science industry.
·
CQV Technical Execution
–
Independently executes and delivers commissioning, qualification, and




validation activities across assigned systems and projects.
·
Negotiation
Skills
– Active listening, needs assessment, and
presents visions to build a consensus.
·
Analytical
Skills
– Identifies, researches, and demonstrates
logical reasoning to communicate critical information.
·
Rational
Persuasion
– Presents key factors, influencing factors,
and strategic goals to assist stakeholders in identifying solutions.
·
Collaboration & Mentoring
–
Supports
clients and junior engineers through technical guidance, effective
communication, and knowledge sharing.
·
Interpersonal
Awareness
– Ability to be aware of how actions, ideas,
and communication can/does affect people and their outcomes.
·
Agility
– Meets objectives by responding to competing and changing priorities and
multiple tasks under inflexible timelines.
Requirements
R
E
QU
I
R
E
D
E
D
UC
A
TI
O
N
A
N
D
W
O
RK
E
X
P
E
R
I
E
N
C
E
:
·
Bachelor's
Degree in Engineering or Life Science.
·
5-7
years of applicable work experience i
n the biomedical and pharmaceuticals industry.
·
Min 3 years of expertise in CQV
·
Proficient
in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
·
Proficient
in developing SOPS, final reports and validation & quality policies.
·
Understanding
of developing, executing and maintaining CQV procedures and policies.
·
Has
good understanding and complies to cGMPs and Data Integrity guidelines.
·
Demonstrated
strategic thinking and implementation skills; proven analytical skills with
ability to translate.
data to actionable plans; demonstrated ability to develop
and implement marketing and product/service.
strategies by converting them into
tactical marketing plans; execute and deliver results.
·
Excellent
presentation and communication skills, written and oral, for a variety of
audiences.
·
Highly
organized in planning and time management, with the ability to multi-task.

📌 Cqv Engineer Ii (Melbourne)
🏢 PSC Biotech
📍 Melbourne