Senior Manager for Packaging
The Senior Manager for Packaging will be responsible for contributing to the technical management and oversight of multiple commercial pharmaceutical packaging projects.
- Oversee and contributes to the completion of all technical and operational packaging activities both locally and globally, to ensure commercial product supply is maintained through management and prioritisation of internal and external resources.
- Lead activities for manufacturing sites, including providing project time lines, resolving issues, on-site troubleshooting, and providing overall technical support; may negotiate pricing for limited-scope projects.
- Direct activities within the group to meet company goals including production schedules, budgeting, training and performance reviews.
- Manage complex processes across functions and interacts effectively with the other team members to ensure packaging systems meet regulatory, performance and cost requirements.
- Initiate and direct the implementation of packaging changes and new packaging introductions on multiple projects across multiple production sites, in line with corporate goals and objectives.
- Coordinate equipment/process qualification (IQ/OQ/PQ) and executes process validation (PV); writes, reviews and/or approves qualification/validation/technical reports.
- Ensure all packaging documentation (Specifications, Master Production Records, Worksheets, etc.) is completed in a timely and accurate manner.
- Generate and maintains Learning Plans and Training Modules. Trains new employees in SOPs and documentation systems.
- Provide technical guidance and training to stakeholder and personnel impacted by the introduction of new systems.
- Lead technical investigations and assessment of deviations and CAPA's
- Contribute to the development of department strategies.
- Responsible for tracking and updating senior management on the project execution status and providing updates on potential challenges and their resolution.
Qualification and Skills Required:
- BS or MS degree in Engineering or Science field, preferably in Chemical Engineering, Pharmaceutical Sciences/Engineering or Mechanical Engineering.
- Demonstrates strong knowledge of Good Manufacturing Practices (GMPs) and working knowledge of regulatory filing requirements and guidance documents. (i.e. SUPAC, PACPAC).
- Demonstrates ability to direct and implement technical/electronic solutions for supporting packaging operations systems (i.e. software, hardware, data analytics, inspection systems).
- Motivated individual, who can work independently, with effective planning and prioritisation skills.
- Excellent analytical/ problem solving skills.
- Excellent verbal, written, and interpersonal communication skills, with experience writing technical reports.
- Demonstrates strong computer, organisational, and project management skills required.
- Ability to function well in small technical groups in a dynamic, fast-paced work environment, working on multiple, time-sensitive projects.
- 8+ years of experience in the pharmaceutical industry and a BS or BA.
- 6+ years of relevant experience and a MS.
Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organisations throughout Ireland, UK & Europe; for more information go to www.berkley-group.com
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Lisa Cooney at 083 337 1056 or send your CV to email@example.com