The Engineering Administrator is responsible for developing corporate engineering documents/ presentation / spreadsheets, Engineering coordination, engineering document management (Digital and Paper based), record keeping, reviews, document control and team follow-ups shall remain key result areas for this role. The person handling this portfolio must ensure that all GMP, projects and compliance related documents are stored properly, and they are easily retrievable, for internal work, internal audit or external audit by an agency. Person must be a strong communicator and must be able to coordinate with site engineering, site leadership teams and corporate engineering teams effectively on several technical aspects.
Essential Functions:
Coordinates and administers assigned configuration management activities relative to identification, control, and accounting of engineering documents, specifications, and vendor documents.
Establishes procedures for and implements the introduction of changes to engineering documents. Reviews and analyzes engineering documents, specifications, and vendor documents coordinates changes with engineering and support the engineering team members at corporate level. Handles correspondence with Site Teams.
Author corporate engineering GMP, and related procedures/ engineering standards and forms as assigned, and work with functional teams to ensure accuracy, feasibility and completeness.
Maintain controlled document master list for engineering and EHS; Maintaining training files and logs.
Supports on site audits by providing documents and information requested by auditor; Review Document control submissions to determine change control impact. Escalate deviations observed in documents to the Corporate engineering management.
Participate in planning, and successful implementation of special requests made by Manager/Project Managers including special information needs such as the need to extract information from documents, assist with engineering travel, provide documents to the travel engineering managers as needed.
Monitors regulatory activity to maintain compliance with regulatory agency requirements. Prepare; record and manage changes to documents. Confirms changes with legal and/ or compliance staff to ensure legal and/ or regulatory compliance. Work with procurement and finance teams to ensure timely follow-ups for payment execution to vendors and government agencies. Assist Capital Plan and Engineering logistics manager for day to day record keeping for asset management etc.
Additional Responsibilities:
Other duties as assigned.
Performs other functions as required or assigned.
Complies with all Company policies and standards.
Education:
Bachelors Degree (BA/BS): Degree in Engineering - Required
Experience:
3 years or more experience in Pharmaceutical or engineering industry is required.
Skills:
Excellent written and verbal communication skills. Good Mathematical ability. - Advanced
Excellent technical writing skills. Must be a Team Player. - Advanced
Excellent oral and written communication skills. - Advanced
Specialized Knowledge:
Adequate knowledge of FDA regulations in pharmaceutical environment. Excellent computer skills; MS Office skills (Word, Excel, PowerPoint, Access, Visio) required.