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Specialist, Manufacturing Automation Mes
3 months ago
Under the management and supervision of the MES Lead, the MES Specialist is responsible for activities that include the following:
- Assure MES and electronic batch records meet ongoing and future manufacturing requirements and is configured to align with regulatory requirements.
- Ensure MES and electronic batch records align with our Company business processes and technical standards.
- Responsible for supporting MES and electronic batch records implementations across full systems lifecycle.
- Identifying business and technical needs of users.
- Determining appropriate implementation of MES technology, executing implementation and maintaining ongoing operations.
- Uses existing procedures to solve routine or standard problems.
- Performs MES training of end users, such as Operations, Technology, Quality, as needed.
- Participate in MES oncall support 24x7 on a rotational basis.
- Builds own team effectiveness skills and promotes team effectiveness through own actions by demonstrating respect and appreciation for diverse perspectives.
- Assist inspections as needed.
FUNCTIONAL EXPERTISE:
- Partner with site users and project teams to meet their needs through MES and electronic batch record configuration. This includes active participation in the configuration of MES and batch records, then handson shop floor training and implementation which may require periodic shift and weekend support.
- Maintain MES as it relates to PAS-X system configuration, SLC, validation development/execution, hardware, software environments, SOPs and business processes.
- Collaborate on occasion directly with MES Center of Excellence (CoE).
PROBLEM SOLVING:
- Uses existing procedures to solve routine or standard problems.
- Applies limited judgment and discretion.
INTERNAL CLIENT/EXTERNAL CUSTOMER FOCUS:
- Responds to standard requests from clients and/or customers.
IMPACT:
- Errors on the job may cause production delays and impact the work of others in own work group.
- Communicates information, asks questions and checks for understanding.
- Has limited decisionmaking authority; works within technical guidelines and direction to achieve objectives and meet deadlines.
- Accountable for technical contribution to project team or subteam.
EDUCATION:
- High School Diploma required.
REQUIRED QUALIFICATIONS:
- 1 year of experience in an operations, quality, or technical role within the pharmaceutical and or life science industry.
- Experience in technical writing or requirements, protocols, and test plans.
- Excellent written and oral communication skills.
- Excellent facilitation, problem solving and decisionmaking skills.
Preferred:
- Knowledge of integrated Manufacturing Execution Systems.
- Understanding of cGMP, and Process Automation System Life Cycle methodologies.
- Bachelor's Degree in Engineering, Computer Science or other technical degree preferred.
PHYSICAL REQUIREMENTS:
- Ability to gown aseptically.
WORKING RELATIONSHIPS:
- Reports to Associate Director, MBR Factory
- Interacts with employees within own department.
- Frequent interaction with employees from other departments.
- Frequent interaction with ERP and Process Automation experts.
- Interacts with representatives from our Company's MES Center of Excellence.
MSJR
NOTICE
FOR
INTERNAL
APPLICANTS
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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