Principal Packaging Engineer
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You will manage CMO’s systems and packaging procedures to align with Takeda acceptance criteria.
Package Tech Transfer, Product Launch and Continuous Improvement project management skills required in managing transfers between CMO’s and internal sites.
You will participate to the design and implementation of harmonized packaging solutions leveraging automated inspection systems reducing opportunities for human error and patient complaints.
You will manage packaging deviations/investigations and trends for assigned products @ packaging CMO.
Will write, update, and implement new, improved quality standards, procedures, and job aids.
Leverage automation to achieve continuous improvement/factory of the future.
You will implement and deliver packaging improvements with stakeholder buy-in.
Defining and mitigating risk of supply disruptions.
You will provide technical oversight of existing packaging production, technology, methods, procedures, and specifications to ensure effective ongoing production and process improvements at CMO
You hold a Degree in Engineering: Packaging/Mechanical/Industrial or Electrical Engineering
Experience (minimum 8 yrs) in Technical GMP pharmaceutical packaging operations.
Knowledge of Global Market Regulatory requirements for finished drug product of pharmaceutical products to optimize packaging.
Expertise in pharmaceutical packaging operations, including the latest industry practices, and product packaging tech transfers.
You are a forward-thinking professional in packaging technology, emphasizing designs that ensure product integrity and enhance stability.
Proficient technical written and oral communication skills
Knowledge of end to end drug product manufacturing processes for OSD/SOD, parenterals including vials, PFS, BFS, and combination products.
You have CMO/Site operations lead experience.
Experienced in product Launch, Market Expansion, Continuous Improvement, and Supply Chain Integrity (including serialization, aggregation and EUFMD)
You are proficient knowledge of global regulatory regulations relating to product packaging (primary and secondary).
You have demonstrated leadership through actions and influence, upholding integrity and demonstrating perseverance in achieving objectives.
Broad influence spectrum, engaging with global Packaging Engineering teams and key stakeholders, ranging from Senior Executives to site-level Packaging Operators across diverse Contract Manufacturing Organizations.
Strong track record of strategic decision-making, integrating both quantitative data and qualitative judgement.
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.
