Senior Process Engineer - API & Small Molecule

International Life Sciences - Solutions de recrutement

For one of our clients, a world leading biotech, we are currently looking for a Senior Process Engineer API / Small molecule to be based in Zug area.

JOB Overview :

In this role, you will be accountable for subject matter expertise in small molecule and to a lesser extent in antisense oligonucleotide (ASO) modalities.

As Subject Matter Expert, you possess a comprehensive understanding of the complete asset lifecycle, which includes performance, design, install, CQV, operation, maintenance, and reliability requirements.

This role and team effectively contribute and add value to all stages of the asset's lifespan, ensuring standards, specifications, strategic approach to manage the lifecycle of the asset ensure optimal performance, efficiency, and longevity.

MAIN TASKS :

The candidate will serve as thought leader on technical projects, site committees, engineering teams, and industry forums.

Objective of this function is to leverage industry-leading subject matter capabilities in small molecule to create an aligned strategic technical direction for our client’s sites & external development and manufacturing operations;

drive cost effectiveness, productivity and compliance.

Primary accountabilities include but not limited to :

Internal Impact - Own strategic technical direction for all types of assets within small molecule engineering. Work across functions and globally to provide technology support to facility, manufacturing projects and site operations by combining engineering principles, facilities knowledge, and design experience to lead the development of value-added technical designs, solutions, and best practices.

Support escalations from site investigations

• External Impact - Pursue intentional, strategic collaborations with external stakeholders and peers in industry. Develop relationships and liaise with Academia and Industry Key Opinion Leaders to provide vision to develop transformative approaches.
• Innovation - Serve as a key innovation catalyst. Working with internal and external stakeholders, expectation will be that experts within this function continuously acquire and maintain cutting edge knowledge of concepts, standards, technologies, and applications for the life science industry and apply such to our global engineering systems where applicable.
• Capital Planning & Execution - Accountable for execution of activities in support to front-end planning and execution of capital projects.
• Lead technical inputs / activities for capital front end planning of potential project opportunities introducing new / advanced technologies;

lead technical ownership of long range planning, tech maps, feasibility studies, and scope definition. Provide technical leadership on capital projects introducing new / advanced engineering technologies as required and ensure capital projects align with small molecule technical standards and requirements via design reviews and site confirmations.

Support technical assessment on any new or revised business development opportunities. Ensure that reliability is integrated into the design, construction, and operation of new facilities, equipment, and systems.

Partnership with Site & External Manufacturing - Add value to site & external manufacturing in multiple ways, via a partnership approach, including establishment and compliance oversight of technical standards as well as support needed to technical challenges and business development opportunities.

Furthermore, this team provides interpretation, consultation, training, and technical decision-making as needed to support adoption and execution of these requirements at the site level.

REQUIRED SKILLS and knowledge

ABOUT YOU :

You are an Engineer with a competent level of depth and breadth in command of the assigned subject matter expertise.

You should have a solid understanding of manufacturing processes related to their assigned subject matter expertise and have demonstrated an ability to apply technical expertise to solve problems.

You have experience working on projects with increasing complexity, taking on more responsibility as appropriate, and would have demonstrated an ability to work collaboratively with cross-functional teams to deliver results.

You have demonstrated capability to lead engineering and CQV on projects / project opportunities that are generally considered to be complex.

SKILLS & EXPERIENCE :

• A minimum of 8 years’ experience in Process Engineering in Biotech, Pharma or equivalent industry
• Knowledge of small molecule API, small molecule OSD
• Experience with an A / E consulting firm is preferred but not essential.
• Expert knowledge and application of FDA and EMEA regulations.
• Excellent leadership, people management, organization, communication, and inter-personal skills are required
• Advanced ability to influence individuals at both site and global level
• Strong communication and presentation skills
• Understanding of asset lifecycle data analytic concepts and methods
• Already established network of technical leaders, peers, and stakeholders in life science industry; Actively participates in industry forums, etc.

Education

• BS in Chemical Engineering or related process engineering discipline
• MS or PhD in engineering discipline is strongly preferred but not required
Vor 30+ Tagen