Manufacturing Senior Engineer

Purpose

Responsible for the management of Production projects including the introduction of new projects and technology into Production, and Manufacturing Improvement. Works in concert with peers or senior staff in other departments to meet project timelines. Responsible for tracking the transfer, implementation and monitoring of projects. Uses SAP, LIMS, PI, and other systems, programs, and databases to input, verify, monitor and analyze pertinent data. Able to identify opportunities for improvement of manufacturing and business processes. Proposes, plans and facilitates the implementation of improvement solutions.

Responsibilities

• Transfers methods into Production instructions to allow for successful performance of scheduled campaigns.
• Schedules work tasks, without assistance, to support project and campaign timelines.
• Drafts broad scope and complexity documents. Circulates the documents to reviewers and without assistance responds to comments and questions. Manages document review and approval to meet project timelines.
• Directs changeover activities with limited assistance.
• Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
• Tracks ongoing problems and gathers information for analysis. Uses analysis to develop solutions to broad-level problems. Presents potential solutions to management and senior personnel, and with limited assistance creates an implementation plan.
• Evaluates data for trends, which may impact other systems, projects, or areas.
• Applies knowledge, experience, and technical skills to understand production objectives and evaluate potential changes, implement production initiatives. Executes systems and procedures efficiently and compliantly and evaluates systems for improvement potential. Develops and uses standard practices to ensure inter-group consistency.
• Works cross-functionally to enhance systems that improve Good Manufacturing Practice compliance.

Requirements

• Bachelor’s Degree or equivalent required.
• At least 8 years’ experience in all aspects of manufacturing and production processes.
• Knowledge of media and buffer preparation, cell culture, and purification of biological drugs is required; Computer and scheduling expertise; In-depth knowledge of safety, quality systems and Good Manufacturing Practices required; Expertise with and continuous improvement of, tech transfer process; Adeptness with equipment, facilities validation, and regulatory filings; Significant functional group management.
• Must be flexible to handle multiple tasks including ability to handle pressure in a professional and positive manner; Effectively works in a team environment; Maintains high level of energy and professionalism on the job; Build effective working relationships with customers, co-workers, cross-functioned groups, and management; Proactively and effectively participates in the continuous improvement process.
• Uses problem solving skills when working on complex problems, where analysis of situations requires an in-depth evaluation of various factors.
• Uses discretion and exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Reports to a manager or higher.
• Coordinates the completion of programs and projects. Decisions, recommendations and actions are essential to the development of suite schedules and personnel allocation.
• Provides technical direction and training to less senior personnel; Coordinates activities of sub-group and actively works with other sub-groups. Acts as advisor to unit or sub-unit becomes actively involved as required. Provides technical direction and training to less senior personnel. Participates in technical investigations and provides on the floor technical expertise; Provides a motivational and team building atmosphere. Acts as a mentor.
• Frequently interacts with subordinates or functional peer groups at various management levels. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects, schedules, etc. Regularly discusses progress, problems, and proposed solutions with colleagues and senior personnel.
• Detailed understanding of current Good Manufacturing Practices as applied to equipment and process steps in area of responsibility. Able to make recommendations for improved compliance at plant level. In-depth knowledge of pertinent regulatory filings. Uses knowledge to prevent problems with regulatory authorities.