Senior Facilities Compliance Engineer
Utilising your experience as an electrical or mechanical engineer, you will help lead various compliance and validation-related projects relating to facilities and maintenance within a fast-paced, innovative, biotech environment.
Like you, we know the importance of your role and offer you a collaborative and supportive environment in which you are encouraged to continually develop your skills and knowledge.
Your customers are at the forefront of genetics and NGS, helping to deliver advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. If you want to push boundaries and join a culture fuelled by innovation, collaboration and openness, then please get in touch.
Responsibilities will include:
Collaborate with Quality, Departmental Stakeholders and other regional and global functions establish requirements and specifications for Facilities
Develop and maintain the regional Facilities compliance action plan
Support turnkey and infrastructure projects on compliance and validations requirements
Develop guidelines, processes and procedures for facilities compliance with appropriate standards and regulations
Engage Facilities Operations and Real Estate and Construction management Teams to fulfill all required Compliance requirements in the action plan
Manage non-conformities (Inc. root cause investigation), CAPAs and follows up on the corrective actions
Take ownership of the Facilities change control process
Develop Validation-related documents (e.g. Validation Master Plans, protocols and risk assessments) and ensures effective implementation
Review technical documents to support compliance requirement
Create and update documents for Compliance requirements
Conduct training for Compliance-related scopes
Lead for facilities in ISO and other regulatory certification programs
Carry out internal audits of the facilities Department compliance
Ensure that all company procedures and policies are complied with and carried out accordingly
Establish improvement through risk-based thinking and analysis
Perform other duties as assigned
Preferred Skills, Experience and Educational Background:
Extensive, relevant, working experience, preferably in Biotech, Pharmaceutical or Semiconductor facilities environment
Demonstrates familiarity with regulatory guidelines and industry standards
Experience in leading Compliance related initiatives and projects
Experience in establishing documentations and protocols
Strong documentation bias and attention to detail
Must be committed and a good team player.
Demonstrates ability to communicate effectively and professionally with internal and external stakeholders
Must be prepared to work overtime when necessary
May need to travel to support regional projects
Must have proficiency with various software applications programs including SAP, BMS, EMS, MS Excel, Word and PowerPoint
Diploma or bachelor’s degree in Electrical or Mechanical Engineering. Or equivalent
Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunities employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.
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