Transformation Senior Process Engineer- API

of this engineering grade level inherently include and expand upon the

established for lower engineering grade levels.

• ◆Responsible for compliance with applicable policies and procedures. Ensures quality and effectiveness of key results of major projects within function through sound design, early risk assessments, and implementation of fallback strategies. Has full awareness of the potential consequences (defects and failure modes) of design changes to established processes. Mitigates risk within functions through sound design, early risk assessments and implementation of fallback strategies.
• ◆Independently plans and conducts high business impact projects within engineering specialty in the Drug Product Manufacturing or Packaging areas. Responsible for achieving the project's financial targets in support of business objectives. Maintains project controls and reporting for cost, scope, and schedule.
• ◆Develops execution strategy including procurement; balances multiple demands; understands the business needs and has a thorough knowledge of the customer and cGMP needs when developing a project scope. Incorporates business foresight of emerging technological trends.
• ◆Facility, Equipment, and Utilities SME

during Regulatory Agencies Audits. Responsible of preparing documentation packages and presenting information in front of regulatory agents.

• ◆Produces unique and cost-effective results. Establishes alternate use possibilities and incorporates flexibility; balances system costs with benefits provided; oversees design work of internal and external consultants, Creates/modified designs for intermediate problems. Integrates financial with technical data. Analyzes complex interdisciplinary problems and identifies their impact; establishes probabilities; draws conclusions reflecting broad business needs.
• ◆Represents engineering on corporate task forces. Identifies full range of customer/client needs and proposes solutions to address them; makes alterations in products or services to better meet (recognized or unrecognized) customer need. Monitors the improvement of other engineer and may participate in the evaluation of assigned staff/project team members and in the identification of development needs. May supervise other engineers or technicians.
• ◆Bachelors Degree in Engineering, science, or closely related discipline is desired, or equivalent technical experience plus demonstrated competence, with a desired 6+ years of significant engineering and/or operational experience. A post-graduate education/degree is desired, and may contribute towards the desired years of experience.
• ◆Has demonstrated competency within a discipline.
• ◆Possesses a strong technical knowledge and application of concepts, practices, and procedures. Works on problems of complex scope where analysis of situations or data involves multiple competing factors. Demonstrates judgment within defined procedures and practices to determine appropriate action.
• ◆Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators. Listens to and understands others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentations.
• ◆Possesses interpersonal skills to negotiate and reconcile differences in a fast paced, goal driven environment.
• ◆Has a technical background in health care, medical devices, pharmaceutical, biologics, or similar industries (preferred).
• ◆Has demonstrated competency with financial systems and in fiscal control.