As the ideal candidate, you are an experienced
Project Commissioning & Qualification Lead
eager to leverage your technical expertise and leadership skills. This role focuses on project execution and involves collaborating across diverse functions, making it an exciting opportunity for a proven leader in the field.
Responsibilities
* You act as the primary C&Q Project Lead on a small molecule site capacity expansion project.
* You lead and manage a team of approximately 20 C&Q Engineers to deliver the C&Q project scope including Facilities and Utilities and Process Equipment.
* You lead and participate in the development and execution of C&Q documentation in accordance with internal Quality Standards, cGMP requirements, and client procedures.
* You manage C&Q team safety during the project.
* You manage scope execution by effectively scheduling, coordinating, mentoring, and reviewing project activities with appropriate stakeholder groups.
* You interact effectively with project stakeholders to execute an efficient and compliant C&Q program.
Criteria
* You have a minimum of
years of relevant business experience
with at least
3 years of leading C&Q Projects
.
* You possess experience with current C&Q methods, including
ISPE
,
ICH
, and
Risk-Based approach
.
* You have experience in C&Q schedule development and maintenance.
* You excel in leading groups of internal and external team members.
* You have experience with
DeltaV-controlled equipment C&Q
.
* You have in-depth knowledge of local regulatory requirements relevant to pharmaceutical facilities.
* You have excellent problem-solving and troubleshooting abilities.
* You are proficient in
English
, with
Dutch
being advantageous.