Primary Responsibilities :
- Support DeltaV PKM training, collaboration, benefit realization, and standardization. The Specialist will follow the standard processes and procedures in performing their duties. These include cGMP regulations, SOPs and global business processes.
- Identify and implement continuous process improvement opportunities.
- Assist in the definition and implementation of an SDLC strategy that supports the flexible use of DeltaV PKM capabilities across the development spectrum.
- Sustain Process recipes and master data, bringing together knowledge of manufacturing processes, and DeltaV PKM capabilities and standards
- Executes the appropriate change control and life-cycle actions and processes to assure the DeltaV PKM system is in a state of control and compliance.
- Collaborates and assists with troubleshooting to efficiently resolve user issues. Knowledge of Quality Systems and Regulatory Standards to provide assurance and foster quality decisions with Development teams and their respective Quality units
Education
- Bachelor s Degree and 5+ years of relevant experience with life sciences systems or 7+ years of relevant experience with life sciences systems
Required Experience and Skills
- Proven track record of analytical skills, problem solving and attention to detail
- High personal integrity, credibility, and energy
- Excellent communication and influencing skills while working with Global stakeholders (North America).
- Strong written and verbal communication skills Minimum five (5) years of experience in a production regulated industry.
- Strong understanding of manufacturing principles/processes (preferably Biologics) and ability to translate manufacturing requirements into Automation/Digital Solutions
Preferred Experience and Skills
- Knowledge of SAP
- Knowledge of Pharmaceutical Technology Transfer processes
