Pfizer Senior Principal Scientist, Automation Lead Analytical R&D in Groton, Connecticut
The Process Control and Automation Lead is accountable for the integration of process and analytical technologies, instrumentation, and automation software and system design across new and emerging semi- and fully-continuous manufacturing platforms in the global facilities used by Pharmaceutical Sciences Small Molecule.
The initial work scope for the role will include collaboration with current technology experts within PSSM, WRD Business Technology, and Pfizer Global Engineering to develop an overarching Process Control and Automation strategy for our innovative manufacturing approaches for both drug product and Active Pharmaceutical Ingredients. This strategy will ensure consistency in control methodology and convention and ultimately timely and efficient transferability as these platforms evolve through Development to Commercial deployment. The role will also (1) be a member of the team designing and implementing the new Sandwich Pilot Plant Process control system, (2) aid the implementation efforts for the PCMM (Portable Continuous Modular and Miniature) platform for solid oral dose manufacture, and (3) design control approaches our FAST (Flexible API Supply Technology) platforms.
The role is expected to work extensively with the PAT and modeling SME's on the integration of online process and analytical needs to the broader system architecture. Effective off-line design and controlled implementation of system updates and robust adherence to structured change control (conducting impact assessments, quality records, etc) are also important aspects of the role responsibilities.
The selected candidate will integrate Process Control, PAT and Advanced Control concepts using existing control software (e.g. DeltaV) to develop control strategies for continuous and hybrid (combination batch and continuous) manufacturing technologies.
Control Systems integration in the first instance working on the Solid Oral dose continuous manufacturing (PCMM) platform.
Control Systems integration design and implementation for the FAST suite of platforms (Flow Hydrogenation, CCID, PFR, LLE).
Consult on System design, specification, and implementation support for the new manufacturing platforms including but not limited to the Process control system at the Sandwich Process Development Facility (API Manufacturing Pilot Plant).
Provide direction and oversight of resources at control system vendors for FAST platforms
Understand and implement current Data Integrity requirements into above designs
Provide support and connectivity to the Scientific Data Cloud effort within PSSM to reuse manufacturing
data to create high fidelity models
Bachelor Degree or Master Degree in Engineering or scientific discipline with 10+ years of experience in Pharmaceutical / Biologics Manufacturing operations with an in depth knowledge of current GMP practices, process automation, computer control system/software integration and Data Integrity
The candidate must demonstrate working knowledge of software programming environments such as Python, Matlab, DeltaV, OSI PI and be capable of hands on coding.
Good written/verbal communication, project management, and collaborative skills are required for this position.
Experience with continuous manufacturing (either API or DP) would be an advantage
Extensive experience in control system integration and information management systems and platforms is a requirement for this position.
Experience with process safety principles, GMPs, GAMP, engineering and quality documentation systems, and change controls is also needed.
Experience with Data Integrity requirements would be an advantage and will help us design the appropriate measures in the first instance.
Ability to operate in a dynamic environment and the ability to multitask and communicate to stakeholders effectively.
Non-Standard Work Information
Role may require some off-hour availability to provide remote support for design, implementation, and/or system troubleshooting for operations in other time zones.
Up to 10% Travel including international locations
Additional Offer Details
Last Date to Apply for Job: October 31, 2017
Eligible for Employee Referral Bonus
Location: Groton CT
EEO & Employment Eligibility
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