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Job Description: PMA Engineer Job Description:
The Process Monitoring and Analytics candidate will be responsible for supporting product robustness for the commercial biologics portfolio in client and third party manufacturing sites. Duties include supporting the Continued Process Verification program through leading meetings, supporting statistical process control documentation and maintaining data analytics systems. The role will include data entry and management of data.

Duties/Responsibilities:
Provide support to maintain the product/site Statistical Process Control (SPC) program, manufacturing performance trending and reporting
Manage and support investigations as a result of robustness events and SPC trending
Provide system administration/maintenance of the Discoverant system
Manipulate existing data files, edit information that has previously been compiled, proofread new entries within the database for accuracy
Create forms/pages for data entry as required and data mine completed Manufacturing Batch Records
Compile, sort and verify accuracy of data to be entered and compare data entered against source documents


Qualifications:
Knowledge of SOPs, cGMPs and the knowhow to work and manage within a regulatory environment
Excellent verbal & written communication skills. Interpersonal/facilitation skills are necessary to interface with and influence all levels of the organization.
Demonstrated ability to take initiative, prioritize objectives from multiple projects, and to adhere to scheduled timelines while maintaining flexibility
Proven leadership skills with the ability to direct and influence a team
Knowledge of MS Word and Excel a must
Strong technical background with knowledge of data management and the ability to work with different data sources across different platforms
Perform hands-on analysis of large volumes of data
Easily pick up new technology
Exceptional attention to detail
Effective time management and project management
Able to learn quickly to work with new databases and create forms for data entry
Experience with data analytics software such as Accelyrs Discovering is preferred
Experience performing statistical analysis and experience using a statistical software program is preferred
Able to coordinate review and approvals of documentation through quality systems
Knowledge of manufacturing operations, especially biopharmaceutical manufacturing operations, is preferred


Education/Experience:
Bachelor's Degree in Chemistry, Chemical Engineering, Biomedical Science or equivalent degree required. At least one year of experience supporting a Continued Process Verification Program is preferred.
Additional Sills: