Engineer QA Equipment, Maintenance and Calibration

Job content

Summary
Supports the Quality Assurance activities associated with the start-up of a new green-field large scale API bio-manufacturing facility.

This position will be the QA support for the site engineering operations Specific duties include the QA review and approval of the equipment qualifications, maintenance and calibration activities.

Duties and Responsibilities
Act as primary QA contact point for all technical aspects on production equipment (risk assessment, improvement projects, changes management).
Act as QA partner for engineering department.
Act as QA SME on equipment qualification during inspections, support manufacturing during inspection presentations and CAPA definition.
Act as back-up for CSV QA engineer.
QA review of equipment qualifications and requalifications (due to changes on equipment, new equipment introduction, and periodical routine requalification as per site VMP).
QA review of engineering technical investigation/deviations impacting equipment.
Identification and follow-up of technical corrective/preventive actions.
Follow-up and review of calibration and maintenance plans and activities.
Ensure compliance during equipment decommissioning/equipment release activities.
QA review and approval of engineering department SOPs and documents.
Support the implementation of the bioplant manufacturing operations (GMP site readiness) as well as the associated documentation.
Lead or contribute to suppliers auditing.
Lead or contribute to the elaboration of risk assessments.
Contribute and support the elaboration of periodic reviews.
Foster the understanding and the application of Good Manufacturing Practices (cGMPs) by bioplant employees.
At all times work in a right first time and site readiness approaches for regulatory inspections (Swissmedic and International).
Contribute positively to a strong culture of business integrity and ethics.
Act within compliance and legal requirements as well as within company guidelines.
Operate in close proximity with engineering and manufacturing in order to foster prevention and anticipation of potential issues as well as the timely handling of unexpected events.

Requirements
Speak, read and write in French and English.
Minimum of 5 years in a Quality Assurance role in a biopharmaceutical manufacturing environment.
Prior successful experience in equipment Qualification.
Thorough knowledge of biotechnology processes.
Demonstrated proficiency in good practice requirements cGMP as well as biopharmaceutical industry regulations and standards related to qualification and validation.
Proficiencies with the quality systems and, preferably, with business processes associated with automation and integration of testing and production systems.
Experience in Health Authorities inspections.
Ability to make pragmatic and compliant decisions.
Strong result orientation and committed team member.
Flexibility and ability to travel.
Good written and verbal communication skills.

Education:
Bachelor’s Degree in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing.
Advanced degree preferred.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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