Position Overview

The Engineering Compliance Sr Specialist assists with the managing of Validation/Automation/Lab Engineering deviations, CAPAs, and change controls / action items, work orders, and assists in supporting other activities required for these groups.

Job Description

Essential Functions:

Responsible for leading / managing the following activities within the Validation/Automation/Lab Engineering departments:

Compliance

• Manages the initiation of new deviations.
• Leads deviation, CAPA, and change control/action item closure for Validation/Automation/Lab Engineering.
• Timely creation of deviation(s) due to validation-based periodic review and requalification efforts.
• Assists with leading Root Cause Analysis Investigations
• Manages continuous improvement initiatives to reduce and/or eliminate deviation re-occurrence.
• Schedules and facilitates post lessons learned.
• Supports leading the completion of periodic reviews / revisions for quality documents.
• Support the engineering organizations during internal and external audits.
• Support the external and internal Audit Programs to be in an acceptable state of compliance.
• Work with Quality and management to implement program improvements.
• Responsible for audit preparations, assisting internal audits and client audits with site documentation collation.
• Provides and maintains metrics around requalification and periodic reviews work orders, including deviation, CAPA and change control status.
• Monitor work order volumes to determine when level-loading should be implemented.
• Act as a Training Coordinator for Validation / Automation / Lab Engineering by verifying training status and updating department training curriculum as required.

Deviation Investigation

• Lead investigations for deviations and events.
• Generate impact assessments for deviations and events.
• Lead investigations including identification of root and/or contributing causes.
• Ensures required Management and Quality approvals on final investigations while satisfying established due dates. Facilitates corrective and preventive action agreement with stakeholders.
• Support client due diligence and Quality audits as well as regulatory inspections.
• Promptly notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.

Equipment Compliance Coordination

• Support the routine maintenance and calibration of Validation equipment by the monitoring and scheduling of any preventive or corrective work required.
• Ensure all equipment utilized on the floor for Validation execution is entered correctly into the Asset Management System.
• Is the point of contact for client and regulatory inspection support with trends and metrics.

• All other duties as assigned.

Required Skills & Abilities:

• Excellent oral and written communication skills, interpersonal and organizational skills.
• Excellent organizational, analytical, data review and report writing skills.
• Practical understanding of equipment used in bioprocessing (downstream and/or upstream).
• Proficient with Microsoft Office applications.
• Good self-discipline and attention to detail.
• Must have flexible work hours - must be willing to work outside of normally-scheduled hours as necessary; including opportunities for alternative shift-hours and weekends as required.
• Ability to multitask and easily prioritize work.
• Ability to work independently with little supervision.
• Experience working in pharmaceutical industry.
• Must have good planning skills and must be willing to interface with and support team members in many different roles and functions throughout the facility.

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:

• Experience prolonged standing, bending, stooping, pushing, pulling, reaching above shoulders and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
• Lift up to 25 pounds frequently and up to 50 pounds, on occasion.
• Attendance is mandatory.

Qualifications:

• Bachelor's Degree in an Engineering discipline or Life Science. Eight (8) years' experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role; OR
• Master's Degree in an Engineering discipline or Life Science. Six (6) years' experience in pharmaceutical or other regulated industry, preferably in Quality Assurance or compliance role.

Preferred Qualifications:

• Experience authoring CAPAs and change controls, and investigating deviations for validation and/or automation.
• Knowledge of validation in pharmaceutical or other regulated industry.
• Experience with leading teams for problem solving.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.