Process Engineer @ CAI | Simplify Jobs

Biology & Biotech (2)
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CAI Overview:

Are You Ready?

CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field tested processes, and elite expertise developed over 30 years.

Our approach is simple because our Purpose informs everything we do:

· We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.

At CAI, we are committed to living our Foundational Principles, both professionally and personally:

· We act with integrity

· We serve each other

· We serve society

· We work for our future

At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing

expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done.

It is absolutely necessary, in order to apply, to be a European citizen or to hold a valid residence permit for Europe.

Key Responsibilities:

1. Major Area 1

Pharma GMPs main regulations knowledge (at least comprehension and/or ability to work on):

- Technology Transfer: at least 4/5 years of experience in a TT team as Process Technology SME (alias process Manufacturing Science and Technology/Process Engineer) or Process Validation SME

- Experience in project management in TT projects or similar context

- Management or involvement in an average number of TT projects (not less than 5 )

- Experience in manufacturing of complex pharmaceutical forms such as: aseptic process of drug product, lyophilized products, biological products, biotechnology/ biosimilar products

Cleaning Validation experience

Other Desired Experience:

- Developing Validation / Verification Master Plans

- Performing formal risk assessments / FMEA

- Change Control

- CAPA process

- Identifying Critical Attributes and Critical Process Parameters

- Commissioning and Qualification

- Developing User Requirements

- Schedule development and execution

- Establishing metrics and leading team to achieve performance goals

- Facilitating meetings

Suitable candidates must be available for travel throughout Italy and some European travel may be required.

La selezione rispetta il principio delle pari opportunità (l. 903/77)

Creates strategies to balance short-term requirements with long-range business plans.

Pursues meaningful initiatives to capitalize on strengths, market opportunities, and counter competitive threats.

Aligns strategic priorities of own area with current direction and strategic priorities of the broader organization.

Apply Commercial Insights

Demonstrates understanding of financial and economic levers that impact business performance and deploys them to improve short- and long-term results.

Promotes best-in-class risk awareness and reviews risk management performance on a continuing basis.

Draws appropriate conclusions from financial reports and analyses to identify and evaluate major strategic priorities and investments.

Focus on Customers

Fosters a customer-focused environment.

Identifies and anticipates customer requirements, expectations, and needs.

Creates systems and processes that make it easy for customers to do business with CAI.

Lead Execution

Maintains accountability throughout the organization and encourages managed risk taking.

Delegates assignments to the lowest appropriate level and keeps people focused.

Monitors progress and redirects efforts when goals change or are not met.

Ensures people have resources, information, authority, empowerment, & support needed to achieve objectives.

Influence and Engage Others

Identifies the agendas, concerns, and motivations of others.

Negotiates persuasively to create win-win solutions for all parties.

Cultivates networks across the organization to garner support and create a foundation for future influence.

Inspires and coaches others to achieve beyond their own expectations and develop a winning mindset.

Build Talent

Provides feedback, coaching, and guidance where appropriate to enhance others’ skill development.

Shapes roles and assignments in ways that leverage and develop people’s capabilities.

Develops successors and talent pools to ensure availability of future talent.

Promotes the recruitment, advancement, and success of the best people from diverse backgrounds.

Achieve Results with People

Fosters a sense of energy, ownership, and personal commitment to the work.

Inspires others to stretch beyond what they thought they could do.

Encourages others to set challenging goals and high standards of performance.

Creates an environment in which performance excellence is rewarded.

Challenges self and others to learn and develop to improve capabilities.

Lead Courageously and Safely

· Develops and drives a safe and inclusive work culture.

Takes well-reasoned stands on important issues and always leads with integrity.

Makes tough people and business decisions and challenges “the way it has always been done.”

Develops breakthrough ideas, safe working processes, initiatives, and business ventures.

DISPONIBILITA' A FARE TRASFERTE SIA ITALIA CHE ESTERO

La selezione rispetta il principio delle pari opportunità (l. 903/77)

#LI-AG1

Process Engineer

CAI

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