Posted in Engineering 30+ days ago.
This job brought to you by Professional Diversity Network, Inc
Type: Full Time
Location: Research Triangle Park, North Carolina
SummaryAs a member of Manufacturing Sciences, the Engineer III will provide technical expertise to the clinical and commercial manufacturing campaigns run at the Parenteral Facility Drug Product site. The focus of this position will be as a site technical expert on fill/finish, visual inspection, and packagingJob DescriptionAs a member of Manufacturing Sciences, the Engineer III will provide technical expertise to the clinical and commercial manufacturing campaigns run at the Parenteral Facility Drug Product site. The focus of this position will be as a site technical expert on fill/finish, visual inspection, and packaging.
As appropriate, responsibilities include:
*Lead technology transfers from Technical Development or external partners to the RTP Drug Product site. Technology transfer will include providing decisions for manufacturing implementation of processes and communicating the decisions to the technology transfer team.
*Author technical reports, protocols and regulatory documents. Support regulatory audits and internal quality organization towards process and batch review and approval.
*Actively pursue technical improvement projects and implement the changes through the global change control process.
*Ability to communicate status of continuous improvement activities, deviations, technology transfer deliverable schedule and metrics for Manufacturing Sciences PF group to management and partner departments.
*Project Management experience in order to facilitate meetings with various stakeholders and communicate to management on the status of programs.Qualifications*Ability to work independently and work as part of a large cross-functional group.
*Effective communication and project management skills appropriate for leadership of technology transfer projects.
*Comfortable analyzing scientific datasets/strong analytical skills with excellent written skills.
*Ability to work well in both individual and leadership capacities
*Knowledge of cGMP, FDA/EMA regulations, Process ValidationEducationBiochemistry, Bioengineering, Biochemical, Chemical Engineering or related discipline: Ph.D. with 0-3 years' experience, M.S. with 2-4 years' experience or BA/BS 4-6 yrs relevant experience in the Biotech / Biopharm industryAll individuals deserve the right to achieve their full potential. Accordingly, our company welcomes all job applicants, and we strive to provide all employees with equal opportunity for advancement. We will not tolerate any form of discrimination or harassment based on an individual's sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by local government agencies or law.As an employer of choice, we strive to:Provide attractive employment opportunities for diverse candidates at all levels and in all segments of our organizationPursue and maintain relationships with sources of diverse candidates, community organizations, and academic institutionsComply with both the letter and the spirit of all applicable laws and regulations relating to nondiscrimination and affirmative action in employmentVEVRAA Federal ContractorWe Request Priority Protected Veteran and Disabled Referrals for all of our locations