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We are seeking a highly motivated, positive and hardworking individual, with automation and instrumentation experience in a cGMP regulated pharmaceutical or biotech environment, to join us as a Sr. Manufacturing Engineer I in OAT (Operational Automation Technology) team. This individual should enjoy working in a multi-functional environment.
Specific Responsibilities for this position include but are not limited to:
- Responsible for system administration, oversight, compliance, troubleshooting, support, performance, improvement and design of automation-based systems used in a manufacturing environment including:
- Customized PC-based systems for manufacturing equipment
- Site Historian Systems (OSI-PI historian and SQL databases)
- Manufacturing Execution systems (MES)
Essential Duties and Job Functions:
- Oversee the Site Data Historian scope which will include:
- Historian application, standards, templates, life cycle management
o Data collection interfaces and configuration for common equipment and systems
o GMP and non GMP reporting and visualization
o Information accessibility to data analytics platforms
- Provide advanced historian and data analytics technical knowledge for troubleshooting, investigations, and training
- Implementing changes to control system hardware/software, and supervising modifications done by outside vendors. This includes development of scopes of work (RFPs), specifications (URS, FDS, DDS) and test plans.
- Sustaining existing automation operations by providing system administration, troubleshooting, investigations and training.
- Supporting capital projects (cost, time, scope) by planning and implementing automation design solutions in collaboration with multi-functional teams.
- Supporting validation of automation systems
- Supporting Quality Engineering to perform Computer System Validation (CSV) risk assessments
- Providing automation system design for data integrity, stability, and interface between different systems.
- Providing periodic alarm reviews of key automation systems, presenting findings and streamlining these systems.
- Creating, revising and maintenance of automation system documentation, including specification documents and SOPs.
- Preparation and implementation of automation change control.
- Supporting definition and implementation of standard methodologies for automation compliance, technical standards and procedures (21 CFR Part 11, GAMP, ISA-88).
- Demonstrate continuous effort to improve operations, decrease turnaround times, streamline work processes, and work cooperatively and jointly to provide quality seamless customer service
- Establish a controlled data management environment through planning, prioritization, , oversight, communication, training, and monitoring data quality by serving as a liaison between the strategic and day to day operational functions
- Ensure responsibilities are upheld for data management, master and reference data management, data quality, data usage, security, privacy, compliance as aligned between the business and IT
- Partner to identify and define key business terms, definitions, business rules, quality requirements, critical data elements, and align across the network.
- Defines and maintains KPIs to ensure data create/change SLAs are being met
- Master’s degree with 4+ years of experience in engineering, manufacturing in biotech/pharma industry Or
- Bachelor’s degree with 6+ years of experience in engineering, manufacturing in biotech/pharma industry Or
- High School degree with 10+ years of experience in engineering, manufacturing in biotech/pharma industry
- Communicate effectively with technology, business personnel and customers (oral and written)
- Experience working on cross functional teams to obtain project deliverables
- Experience with systems investigation and root cause analysis tools
- 5+ years hands-on experience with OSIsoft PI historian
- Experience with MES, BMS, and/or DCS program design and implementation.
- Computer skills in MS office suite, SQL, and or other relational dB tools
- Ability to relate data to business process
- Detailed analytical thinking to evaluate data, identify issues and implement solutions
- Expertise in managing large data volumes and developing automated processes to facilitate routine activities