Transformation Senior Process Engineer- API
About The Position
The Transformation Senior Process Engineer serves as the technical lead for process and equipment design on a Strategic Capital Project. Accountable to the Project Engineering Lead and Project Director, this role drives design decisions, equipment specifications, design accuracy, and project risk management. The position applies scientific and engineering knowledge, mathematics, and ingenuity to technical assignments, generally working with little or no supervision. The engineer independently plans and conducts high-business-impact projects in Drug Product Manufacturing or Packaging, supports project financial targets, and maintains controls and reporting for cost, scope, and schedule. The role also develops project execution and procurement strategies, incorporates customer and cGMP needs, and considers emerging technology. The engineer supports regulatory agency audits as a facility, equipment, and utilities subject matter expert, preparing documentation packages and presenting information to regulatory agents. The role oversees design work by internal and external consultants, develops cost-effective and flexible solutions, integrates financial and technical data, analyzes complex interdisciplinary problems, and may supervise engineers or technicians.
Requirements
- Bachelor's degree in engineering, science, or a closely related discipline, or equivalent technical experience with demonstrated competence.
- Desired 6 or more years of significant engineering and/or operational experience.
- Demonstrated competency within an engineering discipline.
- Strong technical knowledge and application of concepts, practices, and procedures.
- Ability to work on complex-scope problems involving analysis of situations or data with multiple competing factors.
- Judgment to determine appropriate action within defined procedures and practices.
- Ability to interact with diverse groups and maintain strong working relationships with internal and external collaborators.
- Ability to listen to others' perspectives and communicate one's own perspective tactfully and respectfully, orally, in writing, and in presentations.
- Interpersonal skills to negotiate and reconcile differences in a fast-paced, goal-driven environment.
- Demonstrated competency with financial systems and fiscal control.
Nice To Haves
- Post-graduate education or degree.
- Technical background in health care, medical devices, pharmaceutical, biologics, or similar industries.
Responsibilities
- Comply with applicable policies and procedures.
- Ensure the quality and effectiveness of major project results through sound design, early risk assessments, and fallback strategies.
- Assess the potential consequences of design changes to established processes and mitigate risks.
- Independently plan and conduct high-business-impact projects in Drug Product Manufacturing or Packaging.
- Support project financial targets and maintain controls and reporting for cost, scope, and schedule.
- Develop execution strategies, including procurement, while balancing competing demands and incorporating business, customer, and cGMP needs.
- Consider emerging technological trends in project planning.
- Serve as a facility, equipment, and utilities subject matter expert during regulatory agency audits; prepare documentation packages and present information to regulatory agents.
- Develop cost-effective results, consider alternate uses and flexibility, and balance system costs against benefits.
- Oversee design work performed by internal and external consultants and create or modify designs for intermediate problems.
- Integrate financial and technical data; analyze complex interdisciplinary problems, assess impacts and probabilities, and draw conclusions that reflect business needs.
- Represent engineering on corporate task forces and identify customer or client needs and solutions.
- Monitor the improvement of other engineers and may participate in evaluating assigned staff or project team members and identifying development needs.
- May supervise other engineers or technicians.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in short-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
