Upstream Manufacturing Engineer
Our global biotech client need an upstream manufacturing technology engineer to join the team on site for an initial 12 month contract. Responsible for process validation and continued process technical support the successful candidate will be key contributor to a dynamic and highly technical global team. This position will build collaborations with Manufacturing, Engineering, Quality Assurance, Quality Control and Global Regulatory Sciences groups.
- Supports process technology transfer, process validation and the preparation of CMC documentation for regulatory filings.
- Investigation and resolution of process deviations, root cause investigations, CAPAs, process improvements, change controls and preparation of regulatory filings.
- Strong knowledge of cGMP compliance, BMS 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.
- Minimum BSc or equivalent with at least 4 years’ 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 communications 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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