This MES Data Integration Manager position is responsible for performing various tasks in support of the MES nomenclature review process for the integration with Discoverant and MES. This position will provide data support for a wide range of data management and data integration activities. This Manager position will be expected to familiarize themselves with all aspects of department operations and identify further opportunities to use automation or other tools to reduce unnecessary or repetitive work.
Essential Functions Include:
- Review manufacturing record design specifications, identify the data needed to support the Discoverant program, and follow procedures for nomenclature addition and review in manufacturing batch records.
- Provide reliable consistent tags for manufacturing data stored in the MES database to provide a true and dependable integration with Discoverant.
- Coordinate and organize activities for various projects by keeping track of the status, activities, and metrics.
- Obtain specific assignments from ProPharma Group or client Project Manager.
- Ensure individual activities are clearly communicated and documented to Project Manager.
- Review assigned protocols prior to execution.
- Perform technical writing and communicate clearly on all technical, business, and professional interpersonal levels of the organization.
- Apply Computer System Validation experience as it relates to GxP regulated business processes.
- Attend and contribute to scheduled Practice meetings.
- Participate in company programs such as Project Management, Quality, Social Responsibility, Wellness, Safety and Training.
- Create annual personal goals and development plan with administrative manager.
- Other duties as assigned.
Qualified candidates must have:
- B.A./B.S. in Engineering, Life Sciences, or a related field. An undergraduate degree from an accredited university is required.
- Interpersonal skills required to work with team to complete projects and assignments to meet deadlines. People management skills a plus.
- High attention to detail and ability to verify large data sets or work in large data sets or databases accurately required. Ability to review system audit trails a plus.
- Minimum 1-year experience in the field of MES Data Integration Management.
- Minimum 1-year experience in related Pharmaceutical or Healthcare Industries.
- Ability to interpret complex processes and an understanding of process flow.
- The ability to review manufacturing record design specifications and electronic manufacturing batch record builds.
- Experience in the validation of at least one computer system category: automation control, laboratory systems, quality workflow, ERP, clinical data.
- Possess effective written and oral communication skills; ability to write, type, express or exchange ideas of a technical nature by means of the spoken word; convey information/instructions accurately; receive detailed information through oral or written forms and to translate those instructions into physical execution of tasks.
- General business math skills.
- Working knowledge of Microsoft Word, Microsoft Excel, and other word processing programs as may be required by the position (PowerPoint, Access and Microsoft Project may be required) including but not limited to Visio.
- Ability to walk, stand and move about for long periods of time; work with equipment in the field, read, prepare and analyze data for development of reports; ability to sit and type for long periods of time; ability to read and assemble documents as required.
- Basic knowledge of FDA GxPs, FDA Guidelines, and European Guidelines (where applicable) and other regulatory requirements.
- Basic knowledge of industry best practice such as GAMP5, ANSI standards (S-95, S-88), and ASTM (E2500).
- Basic knowledge of 21 CFR 11, including ERES, predicate rule and legacy system requirements.
- All candidates must be legally eligible to work in the United States.
- We are an equal opportunity employer. M/F/D/V
- ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.