Program Manager (Validation, Tech Transfer & NPI)
Program Manager (Validation, Tech Transfer & NPI)
1 day ago Be among the first 25 applicants
Direct message the job poster from CareerWise Recruitment
Contract Recruitment at CareerWise Recruitment
PROGRAM MANAGER (VALIDATION, TECH TRANSFER & NPI) required by CareerWise Recruitment for our multinational Pharmaceutical client at their facility in Galway.
The PROGRAM MANAGER, QUALIFICATION & VALIDATION will have strong aseptic experience, they will be responsible for providing a project management approach and implantation for managing the qualification and validation activities necessary to bring newly built pharmaceutical manufacturing facilities into commercial operation.
Responsibilities:
* Program Management: For facilities, equipment, utilities, computerized systems, alternate source qualifications, with clear and accessible program overview and key metric visibility.
* Qualification & Validation Management: Provide project management approach that facilitates the execution of facility, equipment, and utility qualification (IQ/OQ/PQ) in accordance with GMP and regulatory expectations.
* Regulatory & Compliance Oversight: Ensure facility readiness for regulatory inspections and approvals, including FDA, EMA, and other health authority requirements.
* Cross-functional Coordination: Align efforts across Engineering, Validation, Manufacturing, Quality, and Supply Chain to ensure a seamless transition into commercial operations.
* Risk & Issue Management: Identify potential qualification and validation risks and proactively develop mitigation strategies with relevant stakeholders to keep the project on track.
* Stakeholder Engagement: Act as the primary point of contact for internal stakeholders.
* Budget & Resource Management: Monitor project budgets, optimize resource allocation, and ensure cost-effective execution of programs.
* Operational Readiness & Handover: Develop and execute plans for training, process validation, and initial production batches to ensure the facility is prepared for GMP operations.
* Continuous Improvement: Identify and implement best practices in facility qualification and validation to enhance efficiency and compliance.
Requirements:
* Bachelor's or Master’s in Engineering (Mechanical, Chemical, Biomedical, Industrial, or related field).
* PMP, Six Sigma Black Belt, Lean Manufacturing certified preferred.
* Regulatory Knowledge: Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits.
* Minimum 5 - 8 years of experience in pharmaceutical facility qualification, validation, or technical operations.
* Demonstrated ability to plan, design and manage significant NPI and Tech Transfer projects.
* Strong problem solving and critical thinking skills.
* Excellent communication, writing, presentation and data organisation skills.
* Demonstrated interpersonal and leadership qualities.
Please call Conor Twomey today for further information on 087-0907204 or email: ctwomey@careerwise.ie
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Engineering and Project Management
* Industries
Pharmaceutical Manufacturing and Medical Equipment Manufacturing
Referrals increase your chances of interviewing at CareerWise Recruitment by 2x
Sign in to set job alerts for “Program Manager” roles.
Child Nutrition Programs Assistant Pool 2024-2025 SY
Senior Product Manager - Services (Remote - Ireland)
Galway, County Galway, Ireland 1 week ago
Spiddal, County Galway, Ireland 6 days ago
Customer Success Manager Senior Advisor - EMEA
Galway, County Galway, Ireland 3 days ago
Senior Business Analyst - Project Manager
Galway, County Galway, Ireland 3 days ago
Graduate Construction Project Managers (Consulting) - Ireland - Summer / Autumn 2025 Starts
Galway, County Galway, Ireland 2 weeks ago
Galway, County Galway, Ireland 1 month ago
Galway, County Galway, Ireland 1 week ago
Galway, County Galway, Ireland 1 week ago
Galway, County Galway, Ireland 1 week ago
Tuam, County Galway, Ireland 3 months ago
Galway, County Galway, Ireland 3 days ago
Galway, County Galway, Ireland 1 week ago
Galway, County Galway, Ireland 2 weeks ago
Galway, County Galway, Ireland 1 week ago
Galway, County Galway, Ireland 4 days ago
Galway, County Galway, Ireland 5 days ago
Child Nutrition Programs Assistant Pool 2024-2025 SY
Galway, County Galway, Ireland 1 month ago
Galway, County Galway, Ireland 1 week ago
Program Manager, Qualification & Validation (Galway)
Galway, County Galway, Ireland 5 days ago
Galway, County Galway, Ireland 5 days ago
Galway, County Galway, Ireland 2 weeks ago
Tuam, County Galway, Ireland 4 months ago
Galway, County Galway, Ireland 59 minutes ago
Research Fellow: Senior Clinical Trial Coordinator/Project Manager, CORRIB Research Centre 1 FTE 011114
Galway, County Galway, Ireland 3 days ago
Galway, County Galway, Ireland 6 days ago
Galway, County Galway, Ireland 1 week ago
Resident Program Aide-Part Time Temporary
Galway, County Galway, Ireland 3 weeks ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr