Filling & Purification Ops Support Specialist (cGMP)

Grifols Shared Services North America, Inc; Dublin; On-site; EUR 45,000 - 65,000; Full time

Benefits offered by this job

Salary package

Group pension

Private medical insurance

Career development opportunities

Internal promotion focus

Education allowance

Wellness and social initiatives

Job summary

Grifols Shared Services North America, Inc is seeking an Operational Support SME to drive deviations, CAPAs, change controls and QRM, while ensuring cGMP compliance and quality systems adherence in a Grange Castle Dublin manufacturing setting.

You will lead investigations, provide guidance to Operational Specialists, review batch records, and support on-floor troubleshooting, area readiness, and training material development. A background in biology or regulated pharma is highly valued.

Qualifications

• Bachelor's degree in Science, Engineering, or related field.
• 1-2 years of experience in GMP manufacturing, quality systems, or operational support.
• Strong working knowledge of cGMP and quality systems (deviations, CAPA, change control, QRM).
• Experience in technical writing and documentation (investigations, SOPs, reports).
• Experience in biologics or regulated pharmaceutical manufacturing highly desirable.
• Exposure to audit and inspection processes highly desirable.
• Lean / Six Sigma knowledge or experience highly desirable.
• Strong attention to detail and ability to solve problems effectively.
• Good organizational skills with the ability to manage multiple priorities.

Responsibilities

• Execute operational support activities, including deviations, CAPAs, change controls, and QRM assessments.
• Act as a subject matter expert in one or more areas of operational support (investigations, documentation, training, or QRM).
• Support high-quality investigations, including root cause analysis and identification of effective corrective and preventive actions.
• Ensure all assigned tasks are completed accurately, on time, and in compliance with site procedures and regulatory standards.
• Provide technical guidance and support to Operational Specialists within the team.
• Where required attend FAT, Supplier sites for training and project support.
• Project management as required.
• Author and support closure of deviations, CAPAs, change controls, and QRM records in alignment with quality and compliance standards.
• Ensure documentation (SOPs, RECs, OJTs, QRM files, batch records) is accurate, clear, and maintained in a compliant state.
• Perform detailed record review to ensure completeness and data integrity.
• Provide day-to-day support to manufacturing operations, including batch record review and documentation support.
• On-floor troubleshooting and issue resolution.
• Support for area release and readiness activities.
• Assist in ensuring manufacturing activities are supported in a timely and efficient manner.
• Escalate issues and risks to the Supervisor as appropriate.
• Support development and improvement of training materials, SOPs, and technical documentation.
• Ensure personal training requirements are up to date and support team training compliance where required.
• Identify and support opportunities for process improvements in operational support activities.
• Participate in Lean, Six Sigma, or structured problem-solving initiatives.
• Contribute to improving quality, compliance, and efficiency in manufacturing support processes.
• Work collaboratively with Manufacturing, Quality Assurance, Engineering, and Supply Chain teams to resolve issues and support operations.
• Support effective communication of issues, progress, and risks within the team and to stakeholders.
• Assist with coordination of activities involving contractors and vendors where required.
• Maintain accurate records and ensure proper documentation of all activities.
• Support tracking of KPIs related to deviations, CAPAs, change controls, and documentation timelines.
• Assist in maintaining compliance with training and documentation requirements.
• Provide support during critical manufacturing activities (start-up, tech transfer, campaign execution).
• Perform additional duties as assigned to support business needs.

Skills

GMP manufacturing

Quality systems

Investigations

Documentation

QRM

CAPA

Lean / Six Sigma

Attention to detail

Education

Bachelor's degree in Science, Engineering, or related field

Tools

SOPs

Regulatory records

Technical writing

Job description

Grifols Shared Services North America, Inc is seeking an Operational Support SME to drive deviations, CAPAs, change controls and QRM, while ensuring cGMP compliance and quality systems adherence in a Grange Castle Dublin manufacturing setting.

You will lead investigations, provide guidance to Operational Specialists, review batch records, and support on-floor troubleshooting, area readiness, and training material development. A background in biology or regulated pharma is highly valued.