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Process Analytics Engineer III
Ref No.: 16-00642
Location: Lexington, Massachusetts
Position Type:Contract
Start Date / End Date: 03/21/2016 to 12/23/2016
Primary Duties:
The individual will oversee the design, implementation and maintenance of a real time GMP manufacturing process monitoring program for the PTS floor support team. The individual will have specific subject matter expertise in process analytics and working knowledge of distributed control systems, PI historian, Statistica, LIMS, JMP and other multivariate process analytical tools. Previous project management experience implementing similar systems/programs at other biotech or biopharma companies is also required. Strong cross functional collaboration skills are essential

  • 70% Process Monitoring Project management A key part of this role will be defining end user and customer requirements to define project scope, resources and schedule. The individual will collaborate with/provide guidance to key subject matter experts (SMEs) from the PTS floor support team as well as cross functional groups such as Automation Engineering, Manufacturing systems, Process Development, Manufacturing and the Technical Knowledge Management. Once a project plan is established the individual will drive execution, track progress and provide updates. The individual will be able to assess and design a phased approach in the project plan based on readiness of peripheral systems, design and building of process models and capital/resource availability.
  • 20% Process Data Storage and Communication Individual will also be responsible to development maintain a standardized system for storing and communicating process data. This will include all key process indicators that will be routinely monitoring by PTS floor support and communicated on an exception basis. It will also include a subset of process run data that is readily available and routinely communicate to external customers (Mfg.) and cross functional partners (QA and MS&T).
  • 10% Additional Technical Support As part of the floor support team the individual may be required to provide technical support of ongoing routine event response, containment and investigation support of GMP and/or clinical operations as they align with experience and expertise.

Education and Experience Requirements:
  • The ideal candidate will have a BS in Chemical/Biochemical Engineering or Bio/Chemistry with 10 to 12 years or an MS with 6 to 8 years of applicable process automation, process analytics, technical support or process/facility design experience.
  • Experience with process historian/data collection systems and data analysis/reporting applications such as PI Historian, PI Process Book, Excel, JMP and Statistica (e.g.) is a must.
  • A sound technical knowledge of major unit operations associated with biologics manufacturing such as cell culture, recovery, fluid transfer, filtration, chromatography, CIP/SIP, and UF/DF processes is required.
  • Design or operational experience with large-scale cell culture and protein purification for both clinical and commercial processes is also preferred.

Key Skills, Abilities, and Competencies:
  • Candidate must have working knowledge of cGMPs and statistical analysis methods. As an active participant on multiple cross-functional teams, the candidate must demonstrate excellent written and verbal communication skills.
  • The candidate must also provide guidance and leadership for junior team members for strong working relationship with key business partners and stakeholder with PTS and across all cross functional groups.