Pharmaceutical Ops & Technology
Support Global Engineering Project Execution and assist in maintaining manufacturing process and building automation systems. Participate and/or manage small to medium sized automation projects. Work with internal and external resources to specify, develop, and tests software in support of biopharmaceutical manufacturing. Creates software design specifications, implements new control strategies and develops software test protocols in support of new products and processes. Participate in automation and software system development activities through requirements gathering, vendor evaluation, system design, build, acceptance testing and support. Performs equipment and instrumentation start-up and commissioning activities. Reviews control panel layout and designs including power distribution, grounding requirements and I/O assignments. Able to manage small to medium engineering projects with little direction. Work with and provide some direction to contract software engineers. Participate in multi-function teams to implement change and improve on existing processes.
- Practical knowledge and application of GMP’s and EMEA regulations.Eight years experience working in a biopharmaceutical organization or firm servicing the biopharmaceutical industry.
- Competency in DCS, PLC, DAS systems.
- Proficiency in Lotus Notes, MS Word, MS Excel, MS Power Point and MS Project.
- Excellent oral and written communication skillsAbility to work extended shifts and weekends (when required).
- Project related travel required.
- Experience programming in both DeltaV DCS and Allen Bradley PLC environments.
- Familiar with S88 standards, ISA and MES strongly preferred.Knowledge of cell culture, chromatography and membrane filtration processes.
- Strong project management background.
High School Diploma plus more than 12 years related industry experience or an Associates of Arts Degree with more than 9 years of related industry experience OR a Bachelor’s Degree with a minimum of 5 years related industry experience OR an MBA/MS with a minimum of 3 years related industry experience.