Filling/isolator SME

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Filling/isolator SME

	Location	Denmark
	Job Type	Contract

Blackfield Associates have partnered with a pharmaceutical company in Denmark to find a filling/isolator specialist for initially a one year contract but highly expected to be rolling due to the sheer size of this project.

Responsibilities

As an SME, this person is expected to be a critical role in defining and specifying technical requirements for the filling isolator process, as well as overseeing testing and validation activities. In collaboration with our Central Manufacturing Development team, Senior Project Managers, other specialists, and Subject Matter Experts within the Fill Finish Expansions program, you will contribute to both local and global initiatives.

Your responsibilities will include ensuring that the Filling solution is thoroughly documented and effectively implemented to achieve the desired business impact. Leveraging your experience with Isolator Filling lines, you will work within the Filling Work Package across various technical tracks within the project framework.

Other responsibilities include:

Utilising your expertise to develop technical solutions for various sub-projects within the filling work package.
Leading the development of future process flows, focusing on designing procedures that align with aseptic standards and regulatory requirements.
Playing a key role in overseeing vendors during the equipment design, build, and testing phases, culminating in active participation in Factory Acceptance Tests (FAT).
Providing guidance in the creation and review of test protocols for FAT, SAT, IQ/OQ, and subsequent CQV phases.
Designing and implementing training programs for operations, emphasizing high-reliability manufacturing practices.
Establishing and guide a risk-based approach to validation, ensuring the equipment remains in a validated state, including calibration and maintenance strategies.

This role will have high expectations to be fully onsite.

Requirements

The ideal candidate will have:

A background in engineering.
Over 10 years of experience in aseptic filling operations, with a focus on Isolator Filling technology.
Extensive experience in the pharmaceutical industry or other regulated sectors where GMP (Good Manufacturing Practices) and similar standards are required.
Proven expertise in project work, particularly in the introduction of new technologies or processes.
Excellent verbal and written communication skills in English.
The ability to work under pressure

Apply If this position interests you, and you would like to learn more or explore other available jobs that could also match your skill set, please apply today or email vi@blackfieldassociates.com

Vi Ninh

	UK	+44 (0)2392 314 676
	IE	+353 1 265 5600
	vi@blackfieldassociates.com

See all Vi's jobs

Bio

In early April 2024, I joined Blackfield Associates as an Account Executive. My primary focus lies in Europe, specifically in the countries Ireland, Denmark, Germany and Switzerland. Here, my objective is to build strong connections with candidates while recruiting for opportunities centered around Computer Systems Validation (CSV), Commissioning, Qualification, and Validation (CQV), and Quality Assurance (QA). My previous role as an Account Executive for medical communications has enabled me to maintain key relationships with clients and strengthened my resilience in preparation for recruitment. In my spare time, I love to bake a variety of desserts and explore different restaurants with my friends.

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