Job Description
Global Engineering Solutions (GES) is hiring an Associate Director, Process Engineering to support the Capital Project Portfolio, focusing on Sterile Drug Product (DP) Projects. The ideal candidate will be a Subject Matter Expert (SME) in sterile drug products, with extensive experience in sterile filling, aseptic isolators, and preferably lyophilization (Lyo). Knowledge of drug product formulation and automated inspection is also advantageous. This role will provide leadership within the Large Molecule (Biologics/Vaccines/Sterile) Line of Business while overseeing a portfolio of Sterile Drug Product Projects across two sites in Ireland.
As Process Lead, the Associate Director will implement capital project scopes, apply Lean methods, and execute technical studies that align with business objectives. Reporting to a Technology Director, the Associate Director will manage capital project Process Engineering deliverables from pre-charter activities through process design, commissioning, qualification, and implementation. The candidate will demonstrate strong leadership, interpersonal, and communication skills, guiding assigned engineers and maintaining advanced technical knowledge in sterile drug product applications to support the broader GES Network as a Subject Matter Expert.
In addition to initial assignments, the Associate Director will have opportunities to support the wider portfolio of Biologics, Vaccines, and Sterile needs while gaining exposure to multiple business areas and Lines of Business (LOBs).
Initial assignment will require significant travel (>50%) supporting the regional DP portfolio. Future assignments will include travel (>30%) for project assignments outside of primary location. Travel and flexibility in project assignment location is required; assignments may require short term travel considerations.
Interested candidates who meet the required qualifications and are passionate about contributing to innovative sterile drug product solutions are encouraged to apply.
What you will do:
Bring energy, knowledge, innovation, and leadership to carry out the following:
* Leads development of project scope, front-end planning, and providing innovative designs & solutions that meet business objectives.
* Provides technical guidance during project, assesses viability of technology in proposed configuration, verifies adherence to company standards and practices, and ensures deliverables are technically sound.
* Leads preliminary designs, including P&ID development and HAZOP facilitation.
* Provides leadership during project implementation, including Commissioning & Qualification and post OQ to realize designed assets.
* Collaborates with other Integrated Project Team members and directs the work of vendors/suppliers in preparation of project related deliverables.
* Participate in the development and review of engineering guidelines, standards, safety/environmental policies, and change requests.
What skills you will need:
In order to excel in this role, you will more than likely have:
* Bachelor of Science degree (or higher) in Engineering
* Minimum 8 years experience in engineering, technology and/or manufacturing, preferably within Pharmaceutical/Biotech industry.
* Familiarity with Large Molecule unit operation, engineering design principles, equipment lifecycle approach, and Capital Management stage gate process.
* Advanced understanding of isolated filling, lyophilization, and/or sterile manufacturing design unit design & operations.
* Familiarity with hygienic design principles.
* Creative, innovative, thinks outside of the box, self-motivated, applies problem-solving skills, and solid base in engineering fundamentals and equipment troubleshooting.
* Demonstrated leadership and teamwork skills. Ability to get results in a cross functional environment and has ability to effectively collaborate with and influence partners.
* Effective written and verbal communication skills.
* Project/Time Management skills which deliver on-time and quality work.
Employee Status: Regular
Travel Requirements: Significant travel required for project assignments.
Requisition ID: R334429
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