Upstream Manufacturing Technology Engineer/Scientist
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.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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