Senior Manufacturing Engineer

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make This is an exciting opportunity at our new state-of-the-art facility performing validation activities and process transfer as a member of the technical operations team, supporting the contract manufacturing business unit. The candidate will primarily be responsible for supporting multiple technical transfer projects for the aseptic fill and finish of pharmaceutical drug products. Responsibilities include designing experiments/studies, authoring protocols (e.g., engineering runs; process performance qualifications), reviewing and analyzing complex data, and authoring process validation protocols and reports. Support the development of manufacturing production records. ROLE RESPONSIBILITIES Act as key technical lead for process development. Independently design and manage studies for process development, process optimization, scale-up, manufacturing records and technology transfer.Independently design studies for evaluating the robustness of the manufacturing process. These studies will serve as a baseline for the further process validation activities. Independently evaluate process data and perform in-depth analysis using scientific principles for evaluation of critical process parameters governing the performance of the process. Exercises judgement in selecting methods, techniques and evaluation criteria. Represents Technical operations department as subject matter expert routinely in meetings/conference calls with clients Works with client’s lead technical staff, department management and senior management to evaluate complex technical details pertaining to the project and defines the scope of the project.  Makes recommendations to the business development team regarding pricing and project studies and assist in preparation of project proposals. Function as the Subject Matter Expert (SME) for Manufacturing processes and Technical Transfer of new products in regard to process development. Collaborate with analytical, production, quality and project management team and ensure timely completion of project deliverables. Independently review and analyze complex process data from the clinical and commercial manufacturing batches for conformity and facilitate batch release. Works independently and provide guidance to lower level personnel or as a team member. Execute experiments to support the development and characterization of new manufacturing processes.  Independently manage multiple cross-functional projects that may require regulatory submissions. Effectively present complex technical information to guide decision making. Independently author technical documents such as protocols, reports, deviations, gap analyses, risk assessments, etc. Provide technical support for fill finish manufacturing activities including OOS/OOT investigation, process deviation impact, root cause investigation, process change and optimization. Write and revise SOPs and batch records . EXPERIENCE, SKILLS B.S. in Science or Engineering with a minimum of 5 years of equivalent job experience. Strong leadership skills; high level of personal/departmental accountability and responsibility. Strong understanding of process design principles. Experience with drug product manufacturing processes development, process scale-up and optimization. Ability to perform well under tight timelines and excellent decision-making quality under pressure is desired. Ability to manage multiple priorities and tasks in a dynamic environment. Excellent written and communication skills  Data evaluation and interpretation, including statistics and process controls. Experience and knowledge of sterile processing principles (aseptic or isolator technology).  Proficient knowledge of CGMP.  Regulatory background in pharmaceutical development/research is a plus #LI-Onsite