West Pharma CAPA Engineer 

United States, Arizona, Scottsdale 

16770786

Job Summary:

Supports the execution of the site CAPA program by managing and supporting the CAPA Review Board (CRB) process as an input to the site Quality Management System (QMS). Maintain a safe work environment and ensure compliance with quality objectives and policies. Work with CAPA owners to maintain CAPA program in a proper and efficient manner. Possess excellent oral and written communication skills to be able to communicate at a different organizational level confidently and effectively. Displays good documentation practices, and good manufacturing practices.

Essential Duties and Responsibilities:

• Supports the CAPA process from initiation to closure.
• Supports improvement to the CAPA process.
• May Lead and supports the CAPA Review Board (CRB) monthly meetings presentations.
• Prepares the CRB Monthly presentation.
• Trains CAPA owners on the CAPA process.
• Train or guide CAPA owners in Root Cause Analysis Tools for investigation purposes.
• May support the escalation process as an input to the CRB for CAPA considerations based on trend, product risk, business needs, or compliance risk.

• Supports activities related to the CAPA process with the proper stakeholders and management as needed to ensure a proper and timely CAPA execution process from initiation through implementation and closure.
• Report CAPA statuses to upper management as needed.
• Maintain CAPA metrics in compliance with internal procedures and goals.
• Coordinate CAPA activities to ensure on time completion: CAPA meetings, ad hoc meetings, etc.
• May review and approve CAPA investigations and CAPA Extensions with a high level of scrutiny.
• Provides guidance and feedback considering Regulatory and standards requirements: FDA 21CFR Part 820, ISO 13485, GxPs, ISO 14971, etc.
• Understanding operational processes such as Work instructions, validation process, calibration process, preventive maintenance, manufacturing processes to provide proper recommendations during the CAPA process to ensure effective investigations are driven.
• May present CAPA information in the Quality Management Systems Management Review.
• Supports during internal/external audits during CAPA auditing process.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.

• Exhibits regular, reliable, punctual, and predictable attendance .

• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
• Maintains a clean, orderly, and safe workstation and environment always.
• Performs other duties as assigned based on business needs.

Basic Qualifications:

• Education or Equivalent Experience: Engineering Bachelor’s Degree or equivalent
• Experience: 3-5yrs CAPA process experience in a manufacturing operations site.
• CAPA process Experience

• Root Cause Analysis Experience

Preferred Knowledge, Skills, and Abilities:

• Excellent communication ability, verbal and written communication skills to be able to communicate effectively at different organizational levels.
• Computer Skills
• Ability to meet deadlines.
• Strong problem-solving skills.
• Demonstrates knowledge on Root Cause Analysis methodologies (i.e, A3, 5 Why’s, 6M’s, 8D’s, DMAIC, etc.).
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Strong data analysis skills
• Organized and detail-oriented and self-motivated.
• Knowledge in Medical Device Regulatory Requirements and MD Standards: 21 CFR Part 820, EU/MDR, ISO 13485, ISO 14791, GMPs, GDP.
• Project Management Experience.
• Experience on report writing.
• Validation process knowledge.
• Experience working with Manufacturing operations.
• Ability to work with teams and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.

Travel Requirements:

Physical and Mental Requirements:

• Medical Device manufacturing requires strict adherence to standards. Working environment is a manufacturing facility, which houses plastic injection molding machines. Must tolerate fumes and particulate generated from various plastics. Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition. Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.
• May stand or sit for extended periods of time. Must transport oneself to and from other areas of the facility and travel to other divisions when necessary. Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear audible alarms from distances up to 150ft.
• The ability to be able to lift and carry various items up to 50lbs. Medium – exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects.