Senior Process Improver- Packaging- CRMO
CooperVision
Alajuela, Costa Rica
hace 3 días

JOB SUMMARY

Oversees the Business Unit performance on key packaging processes and equipment. Assures key performance indicators (KPI) are improved through a structured and scientific approach.

Provides technical coaching and guidance to other BU members. ESSENTIAL FUNCTIONS

Coordinating Packaging improvements implementation

Creating troubleshooting guidelines and / or applicable SOPs for process and equipment and repair

Identifying process and / or Packaging equipment not performing as expected

Defining and prioritizing Process KPIs for improvement

Developing measuring Process KPIs for improvement

Analyzing through a structured approach to identify root causes

Improving Process KPIs performance

Developing control mechanism to ensure Process KPIs consistency

Designing and Coordinating Engineering Tests / Q's

Executing Engineering Tests / Q's

Documenting and Reporting Results of Engineering Tests / Q's

Designing and programming of Process automation Improvement systems

Providing technical solutions that increase utilization and reduce costs

Eliminating service interruptions and avoid unplanned downtime on manufacturing lines

Developing process and regulatory documentation for automation systems

Performing and documenting engineering studies

Reviewing / Modifying Standard Operating Procedures for Engineering Controls

Assuring Readiness of Packaging Requirements for the Product Transfer

Assuring Operator and BU's resources have the Skills and knowledge to receive the Product Transfer

Receiving and Implementing Product and Equipment Transfer

Assuring Readiness of Packaging Requirements for the Optimization Efforts

Observing, Analyzing, Documenting & Recommending the Start-up of Optimization Changes

Defining Packaging equipment maintenance requirements

Developing PM procedures for Packaging Equipment

Executing PM activities in Packaging according schedule

Verifying PM tasks effectiveness in Packaging

Implementing Equipment’s Upgrades and Optimization Changes

Documenting all Equipment Changes

Liaison with Packaging Corporate Technical group

For the Secondary Packaging Business Unit

Ensure packaging priorities are followed as per Planning requirements

Monitors unit performance to ensure agreed targets are achieved

Vacations & Overtime Administration for Exempt and Non- Exempt

POSITION QUALIFICATIONS KNOWLEDGE, SKILLS AND ABILITIES

  • Knowledge of FDA current GMP / QSR regulation
  • Excellent oral and written communication skills in both English and Spanish languages

  • Teamwork and service oriented
  • Effective leadership
  • Computer literate (PowerPoint, Word, Excel)
  • Willing to travel
  • Excellent interpersonal skills; Highly motivated, self-starter, and responsible person

    WORK ENVIRONMENT

    Generally, works in a closed environment, in office conditions, with moderate level of noise and controllable changes of temperature

    Needs to stand, walk and may be seated for a long period of time

    Uses hands to feel, handle and reach

    Works with a personal computer and programs to prepare documents or reports

    Applies communication skills (advanced reading, writing, and technical skills) and mathematical concepts knowledge to perform work and coordinate with others

    Needs to have high analytical capacity and level of professionalism and judgment to resolve problems

    EDUCATION

    Bachelor’s degree in engineering : (Industrial, Chemical, Mechanical, Electrical).

  • Master preferred.
  • EXPERIENCE

    Five to ten years of experience with similar responsibilities in a regulated industry (medical devices / pharmaceutical highly desirable)

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