Engineering Systems Specialist - Field Based

This is where you save and sustain lives

At Baxter we are deeply connected by our mission. No matter your role at Baxter your work makes a positive impact on people around the world. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.

Baxters products and therapies are found in almost every hospital worldwide in clinics and in the home. For over 85 years we have pioneered significant medical innovations that transform healthcare.

Together we create a place where we are happy successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining liveswhere your purpose accelerates our mission.

SUMMARY

This role is intended to support the maintenance performance and improvement of the Engineering Quality Management Systems within the UK and Ireland Compounding cluster to ensure defined goals and performance objectives are achieved.

• The role will facilitate and support improvements and to Engineering Production and QMS systems/processes through the analysis of data to ensure areas of nonconformance and opportunities for improvement are identified and addressed in a timely manner.
• The role will additionally handle the Engineering function within Baxter QMS.
• Support projects and continual improvement opportunities with the objective of improved compliance with specified regulations and standards of quality reliability and cost improvements.

This role reports into Compounding Engineering Management and will be field based to support UK & Ireland sites as required with audits project support and face to face meetings. The Role will be required to communicate with and provide support within the engineering function for quality compliance to the following primary functions within the UK and Ireland Compounding cluster:

Communicate with Engineering reps from EMEA and ANZ sites to align methodologies and support reviews.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Support the consistent application of the Baxter Quality System within the Engineering function across the UK and Ireland Compounding organisation in the areas of:

• Perform gap assessments on global and regulatory standards against local SOPs and practices
• Completion of engineering tasks within the QMS in accordance with timeline stipulations
• Provide and handle risk mitigation for FMEA gap assessments and retain required evidence
• Conduct Engineering Impact Assessments within the TrackWise 8 (TW8) Change Control process
• Facilitate timely management for QMS tasks allocated to the Engineering Department
• Keep an eye on Engineering key performance indicators in the Baxter QMS
• Support Project Management functions in effective delivery of projects
• Support and lead investigations regarding engineering breakdowns using PPS tools and ensuring effective and timely communication to impacted collaborators
• Support Internal Audits in line with the Internal Audit Schedule as Support Auditor.
• Support Internal Corporate external Regulatory and Customer audits through provision of requested documentation records and information in a timely manner.
• Provide Information in support of audit findings and NCRs across the UK Ireland Compounding cluster to ensure impacted sites are made aware can evaluate impact of findings and initiate preventive actions.
• Support initiation and progression of supplier Complaints in TW8 with assigned Owners and Users to ensure timely closure.
• Support Compliant investigations and raising blocking issues to SNCR/NCR.
• TrackWise 8 NCR/CAPA/CQI/CPI (TW8) System User
• Initiate and progress NCR/CAPA/CQI/CPI in TW8 with timely closure.
• Support update and maintenance of local NCR/CAPA/CQI/CPI procedures and processes in line with Corporate Compounding and Regulatory requirements.
• Support identification of quality system process improvement opportunities identified through NCR/CAPA/CQI/CPI trends.
• Support maintenance of effective change control process to ensure all changes are fully documented and impact of change evaluated across the UK & Ireland compounding cluster.
• Review proposed Change Controls prior to initiation and seek authorization to proceed via Change Control Review Board process.
• Track and monitor the progress of initiated Change Controls to ensure timely completion.
• Ensure all change control deliverables are completed prior to closure of a Change and submit for Change Control closure.
• Support the country / local initiatives and projects as per request in alignment with the UK and Ireland Compounding needs.
• Adhere to Environmental Health & Safety (EHS) policies procedures and requirements.
• Support maintenance of a safe place to work by addressing blocking issues related to unsafe EHS practices
• Support with and conduct risk assessments in line with EHS guidance
• Maintain professional status and standards
• Fully support the Quality Policy and Business Goals and Objectives by building quality in to all aspects of work.
• Identify new or changes to existing processes and systems to improve effectivity and efficiency of the Engineering function whilst maintaining compliance with Corporate and Regulatory requirements.
• Support Project Managers for CAPEX and Continual Improvement projects to ensure required resources project impact and risks are identified and managed to deliver improved compliance quality reliability and measurable cost savings.

JOB REQUIREMENTS

• Degree level or equivalent experience in Pharmaceutical Biotechnology Chemistry Microbiology / Engineering.
• Minimum of 3 yrs experience in quality team facilitation project management process improvement or quality data analysis role.
• Minimum 3 yrs experience in Pharmaceutical Medical Device Biotechnology Chemistry Microbiology or other related regulated industry.
• Proven knowledge of Quality System processes (essential) with working knowledge of current EU and UK GMP requirements (EU GMP Annex 1) (preferred) or experience of working within ISO 9001 ISO 13485 MDD 93/42/EEC or similar regulations and standards (considered).
• Experience of coordinating and supporting Document Control Internal Audit CAPA Nonconformance and Complaints processes (required).
• Experience of problem solving using Root Cause Analysis techniques such as 8D GEMBA 5 Whys Cause and Effect (preferable).
• Internal audit experience.
• Working knowledge and hands on experience of software tools to manage Quality Systems processes such as TrackWise (preferable).

What are some of the benefits of working at Baxter

• Competitive total compensation package
• Professional development opportunities
• High importance placed on work life balance
• Commitment to growing and developing an inclusive and diverse workforce

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.

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