Upstream Manufacturing Technology Engineer/Scientist
This vacancy has now expired
Upstream Manufacturing Technology Engineer/Scientist required to join a Global biotech company located in Dublin for an initial 12-month contract.
An exciting project there is lots of opportunities to learn new technology and develop current skills within a fast-paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.
Essential Duties and Responsibilities for this Upstream Manufacturing Technology Engineer/Scientist role include, but are not limited to, the following:
- Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings for the facility.
- Investigation and resolution of process deviations, root cause investigations, CAPAs, process improvements, change controls and preparation of regulatory filings.
- Strong knowledge of cGMP compliance, corporate, site and regulatory agency requirements.
- Assists in evaluating process performance by comparing manufacturing data to historical data from other sites.
- Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process.
- Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies, representing the client site.
- Minimum BSc or equivalent with work experience in cell culture or purification manufacturing technical support in the biopharmaceutical industry including experience with process validation.
- You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills.
- Excellent verbal & written communication skills. Interpersonal and facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams.
- You have proven problem-solving ability, project management skills, including leading cross-functional teams and balancing multiple project assignments.
The candidate must have the rights to work in the location stated in the job advert.
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