MES (Manufacturing Execution System) Werum/ Korber PASX Engineer

Duration: 06 Months

The Digital Operations Technology (DOT) Group is responsible for design, implementation, support, and maintenance of Information Technology solutions in support of site goals and objectives. The group is also responsible for implementing and advancing Digital technologies to be at the forefront of Industry 4.0. In such, DOT Group is responsible for maintaining a stable, Qualified, and highly available computing infrastructure and implementation and Validated computer systems. This encompasses work processes that originate with the identification of a new or revised system, the design, installation, verification and validation of the system, the maintenance of the system in DOT commissioned/qualified/validated state and the retirement of the system at the end of DOT life. Additionally, through daily tasks, DOT supports current project operations and ensures compliance with regulatory, corporate and site requirements.

Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.

The primary responsibilities will be with the MES team but may require cross-training with other groups within the DOT group. Additionally, the DOT group continues to progress DOT Digital offerings in continued support of advanced manufacturing operations. This role will support these digital efforts.

This position will be an Electronic Batch Record designer for the Manufacturing Execution System (MES). Primary responsibilities include developing innovative, flexible, and robust batch records. Close collaboration with a cross-functional teams will be required to deliver batch records. The person will be responsible for maintaining and providing technical support for and ensuring availability of the MES and associated batch records for multiple manufacturing facilities. The person will also provide expertise with the MES system to enhance a digital, integrated shop floor. The person will provide batch record configuration expertise to develop complex and novel solutions as required. An understanding of automation, manufacturing processes, and ERP will be required to be successful in this role.

Responsibilities include:

• Problem Solving:

o Provide technical solutions to a wide range of difficult problems through individual efforts as well as strategic leveraging of outsourced personnel. Solutions are imaginative, thorough, practical, and consistent with organizational objectives.

• Production:

o Responsible for ensuring MES and potentially other manufacturing related computerized systems are available to support Operations Schedule Adherence requirements.

o Managing small to medium projects related to MES and ensuring that the appropriate controls, approvals, and validation requirements are implemented.

• Training /Deviations /Compliance:

o Complying with Client’s requirements for training, maintaining training at or above 95% on time.

o Utilizing quality systems to measure, analyze, and improve team performance.

o Participate in staff meetings, providing updates of department activities and project statuses.

o Ensuring that Process, Equipment and MES documentation is compliant and inspection ready.

o Participating in inspections conducted by external regulators.

o Partnering with direct and indirect management chain to ensure the following:

? Designing Department Training Plan and managing execution.

? Ensuring Inspection Readiness of assigned areas.

? Overseeing completion of investigations and deviations.

• Safety

o Complying with requirements from client’s Safety Program including Health and Safety regulations and OSHA requirements.

• Continuous Improvement:

o Working collaboratively with inter-department and cross-functional teams to lead necessary changes in a timely and productive manner.

o Identifying opportunities to improve manufacturing processes and practices.

o Ensuring all manufacturing management tools/systems and documentation (SOPs, MBR's, OJTs) is accurate.

o Partnering with Manufacturing to troubleshoot and drive resolution of process issues and proactively driving projects to improve manufacturing process.

o Partnering with Operational Excellence to drive business process improvements through Kaizens, Kanban, 5S and VSM in their area of responsibility.

Ensuring that internal customers and suppliers are aligned with the solutions and services of the department.

Basic Qualifications:

• Bachelor’s degree in engineering, Science and 1 to 2 years relevant work experience or 5 years of relevant work experience.

• 1 year of electronic batch record editing experience with one of these MES Systems Koerber/Werum PASX, Emerson Syncade, Siemens Op Center, or Rockwell- FactoryTalk Production Centre.

• Direct experience with regulated environments (i.e. cGMP, OSHA, EPA).

• Demonstrated knowledge of validation requirements for control systems in CGMP and/or ASTM environments.

Preferred Qualifications:

• Master’s with 1+ years of relevant work experience.

• MES Koerber/Werum PAS-X batch record editing experience.

• Experience in OSI PI system maintenance and configuration activities

• Experience with DCS systems

• Experienced in establishment of safe practices in a cGMP environment.

• Proficient working with computer programs/applications such as Windows, VBA, MS Word, Excel, Access, etc.

Special Working Conditions:

• Required manufacturing operations support on a rotating “on call” 24/7 basis.

• Resource will be expected to follow our procedures for making GMP batch record changes, including following existing Client’s change management procedures including ITSCR (Information Technology Change Request) creation and execution.

• Resource will be expected to make batch record edits, update functional specifications, develop and execute test protocols, develop and execute regression testing, coordinate with other client’s functions for requirements definition, work planning and execution, as well as work independently to make changes.

• Bachelor’s Degree

Comment:

 This role will be supporting multiple buildings within our new 'green' Resource needs to be able to work EST hours and come to the site in Framingham, MA as needed (hybrid role). Top Must-Have Skills • Experience in Pharma industry. • GMP Experience/ Documentation Ex: batch record edits, update functional specifications, develop and execute test protocols • Resource needs to be able to work an on-call rotation with night/ weekend support for operations as needed. • Resource should be fully trained and experienced (1-3 years) on Werum/ Korber PASX with batch record editing. We will train resources on Client’s procedures but expect them to know the PASX system already. Nice Have: • Automation systems 1-2 years • Biotech process development Word docs.

Shift: Day