SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

The Facilities Operation Specialist is responsible for periodic review of Facilities/Utilities Department documentation and records such as logbooks and maintenance work records to assess for compliance with established quality standards, policies, and procedures. Participates in, and acquires results of, all Facilities/Utilities Department quality and regulatory audits.

Main Responsibilities

• Manages and provides support, information, and assistance to the sitewide asset management system
• Acts as a liaison between the Facilities/Utilities Departments, Production Department, Quality, ME, MS, AS and regulatory groups to define and address all issues of non-compliance
• Lead and participate in Cross Functional Facilities/Utilities Department issues of non-compliance to ensure all activities related to the investigation and resolutions of non-conformities are performed in a timely manner and in compliance with Quality procedures and regulatory requirements
• Facilitate reviews and revisions of Facilities/Utilities related Standard Operating Procedures, Work Instructions, Risk Assessments, and OJT Task Evaluations for each group within the Department.
• Ensures written content meets all regulatory requirements and meets the SHL Medical Validation documentation standards other internal policies, procedures, and best practices
• Maintain a thorough knowledge of departmental policies, procedures, and Contacts/Venders
• Ability to build strong relationships with key staff members and stakeholders
• Ensure timely and appropriate communication occurs with all client stakeholders
• Extensive self-study, training and testing are required
• Utilize a variety of tools including web portals, inline documentation, pdf documents, product walkthroughs
• Engage with necessary stakeholders to document procedures, policies, and reports in a standard, approved format
• Gathers, analyzes, translates, and composes technical information into clear, readable on-line information pages and documents to be used by technical and non-technical personnel
• Collaborate with individuals and groups with the initiation, review, submission, and follow-up of documents such as Change Controls and Corrective and Preventive Action plans, Validation and Commissioning documentation.
• Provides periodic review of Facilities/ Utilities Department documentation and records such as logbooks and maintenance work records to assess for compliance with established quality standards, policies, and procedures.
• Participates in, and acquire results of, all Facilities/Utilities Department with Quality audits.
• Assist and take ownership of the Facility change control program, deviation, events, and CAPA.
• Write Facility Department Investigations including Standard Operating Procedure, Change Control, Preventive Maintenance, Work Instruction, etc.
• Provides support and training for Facilities/Utilities personnel on regulatory and Quality topics, such as accurate documentation procedures and the use of QMS, SAP CR, CC TC  
• Supporting the management in Contractor Management and Pricing 

Skills and Qualification

• Bachelor’s degree Technical Communications, or any relevant field
• Excellent communication and interpersonal skills.  
• Strong knowledge of terminology used in the Biopharma and or medical field industry.
• Ability to work independently. 
• Knowledge of relevant regulatory requirements, including FDA regulations and ISO standards.
• Supporting the Facilities/Utilities management team

Preferred: (nice to have)

• A minimum of 3 years’ experience in BioPharma or Medical Manufacturing is preferred.

We Offer

• Competitive compensation package
• Modern working environment with state-of-the-art facilities and technologies
• Challenging assignments in a fast growing and innovative industry
• Position in a dynamic, international team of highly skilled professionals
• Various opportunities for personal and professional development within a global organization

Please note that SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check.

For more information on SHL Medical, please visit: shl-medical.com