Published: March 2, 2018
- Fully responsible for managing strategic projects/activities with accountability for results in terms of alignment across business units, cost, methods, agility and efficiencies.
- Creates, develops, and administers teams, budgets, schedules and performance standards per business division or site goals and priorities.
- Responsible for preparing plans for technology transfer and leading and coordinating activities that involve cross functional groups such as Plant Engineering, Incoming Quality Assurance, Manufacturing Engineering, Quality Engineering, Compliance Assurance, Documentation Control, Materials and Logistics.
- Leads the product transfer efforts and is the primary contact for the receiving facility.
- Serve as liaison between the Division Design team and Manufacturing plant personnel. Also, responsible for managing the budget for assigned projects.
- Directly participates in establishing and administering multiple functional projects per the company’s goals and priorities.
- Acts as an advisor to team members to meet schedules or resolve technical or operational problems.
- Main point of contact during transfer projects involving Divisions and Corporate.
- Acts as internal consultant for other projects within Corporate and Divisions.
- Responsible for providing project updates to Plant and Division Senior Staff.
- Leads the continuous improvement efforts for technology transfers and product/process validations systems.
- Follows and observes all regulatory aspects within the projects and/or area of responsibility (QSR, ISO, FDA, internal policies).
- Leads cross-functional teams for the development and implementation of new products and/or processes.
- Reviews and approves change requests (CR's) related to the technology transfer project to ensure completeness and accuracy.
- Contributes to the implementation of process improvements, new products, or methodologies aligned with business strategic objectives.
- Solves complex technical issues during process development phases to minimize risk to new product launch timelines.
- Provides coaching/mentoring on areas of expertise, such as project management, for flawless transfer execution.
- Oversees process qualification activities from determining validation requirements to final process release.
- Responsible for generating the annual capital budget as well as managing the capital budget for assigned projects.
- Benchmarks and identifies new technologies to apply on current and/or new products.
- Serves as the Subject Matter Expert for products/process validations at the plant.
- Documents projects’ lessons learned and best practices.
- Assures proper handoff of new product lines to the manufacturing organization.
- Assures he/she and his team are properly trained before performing any task.
- Uses the required clothes, personnel and security protective equipment per operations requirements.
- Complies with the cGMP’s and Quality Standards and established policies and/or procedures.
- Executes other duties assigned by his supervisor.
- Bachelor’s Degree in Engineering with experience in capital equipment procurement and justification.
- 5 to 10 years of experience in the pharmaceutical and/or medical device manufacturing industry.
- Excellent leadership, analytical, interpersonal, and time management skills, with a minimum of 5 to 10 years of work related experience within the pharmaceutical and/or medical device industry.
- Excellent ability to apply statistical concepts such as process capability analysis, process control, hypothesis testing, Multi-Variant Studies, Gage R&R, regressions and other advanced continuous improvement tools to ensure prompt and cost effective solutions to complex problems.
- Knowledge of cGMP’s, risk assessment techniques, demonstrated excellent technical writing skills through validation protocol development, process development, validation report documentation, and release of standard operating procedures.
- Ability to read, analyze, and interpret technical and financial reports.
- Strong knowledge and experience in manufacturing processes such as heat sealing, thermoforming, molding, laser welding, adhesive bonding, mechanical assembly, and measurement systems.
- Strong computer skills; MS Word, MS Excel, MS PowerPoint, MS Project, Minitab, etc.
- Excellent leadership, analytical, interpersonal, and time management skills.
- Must be bilingual (English/Spanish) and must have good communication skills, both oral and written.
- Team work oriented.