Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
We are looking for a Senior Manufacturing Specialist - Isolator Technology (Permanent role) to join our team in Leon, Spain. This is a Monday to Friday role.
Main Purpose Of Role
The Senior Manufacturing Specialist - Isolator Technology serves as the technical expert (SME) for manufacturing operations, with particular expertise in aseptic filling processes and isolator technology, providing advanced technical leadership and support for complex manufacturing processes in compliance with FDA and other regulatory requirements, while ensuring adherence to safety and quality standards.
This role drives process robustness, operational excellence, troubleshooting, deviation investigations, risk mitigation, and continuous improvement initiatives to enhance manufacturing performance.
This role collaborates cross-functionally with Quality, Development, Engineering, Validation, and Operations teams, leading and coordinating technical activities across the organization. In addition, this position may provide technical guidance, prioritization, and oversight of other Manufacturing Specialists to ensure effective execution of departmental objectives.
As the recognized subject matter expert for aseptic manufacturing, filling operations, and isolator technology, the Senior Manufacturing Specialist is expected to influence strategic decisions, support regulatory inspections and audits, lead technical investigations, and champion innovative solutions that improve process capability, contamination control, compliance, productivity, and product quality.
Main Responsibilities
- Ensure compliance with all GMP requirements, manufacturing procedures, and applicable regulatory standards.
- Serve as the site Subject Matter Expert (SME) for aseptic filling operations and isolator technology, providing technical leadership and guidance to Operations and cross-functional teams.
- Drive efforts to address manufacturing and regulatory compliance issues, ensuring timely resolution and implementation of sustainable corrective actions.
- Provide technical direction, prioritization, coordination, and follow-up of other Manufacturing Specialists to ensure effective execution of departmental objectives.
- Lead the development, review, and continuous improvement of manufacturing documentation, procedures, work instructions, and technical standards, ensuring alignment with regulatory requirements and business needs.
- Define and maintain best practices related to aseptic processing, filling operations, contamination control strategy (CCS), and isolator technology, ensuring compliance with Annex 1 and current industry expectations.
- Lead and support investigations, deviations, change controls, CAPAs, risk assessments, and other quality events to ensure the maintenance of the required quality standards within the manufacturing organization.
- Review and approve manufacturing batch documentation, ensuring accuracy, completeness, and compliance with established requirements.
- Develop and deliver training related to manufacturing processes, aseptic practices, filling operations, and isolator technology, ensuring appropriate knowledge transfer and capability development across the organization.
- Identify, lead, and implement continuous improvement initiatives focused on process robustness, contamination control, operational efficiency, productivity, cost reduction, and product quality.
- Actively participate in and lead manufacturing-related activities associated with new product introductions, technology transfers, equipment implementation, process improvements, and facility projects.
- Represent Manufacturing in cross-functional teams, providing expertise for equipment testing, commissioning, qualification, validation activities, and operational readiness.
- Provide technical leadership during troubleshooting activities involving aseptic processes, filling equipment, isolators, and critical manufacturing systems.
- Establish priorities and make data-driven decisions based on production plans, business needs, compliance requirements, and operational risks.
- Maintain a strong shop-floor presence, supporting manufacturing operations and providing technical coaching, mentoring, and guidance to operators and specialists.
- Collaborate with suppliers and internal stakeholders to evaluate new technologies, equipment enhancements, and improvements related to aseptic manufacturing and isolator systems.
- Collaborate to continuously improve working conditions, operational practices, and overall manufacturing performance.
- Promote and demonstrate the Company's values through technical leadership, talent development, teamwork, transparency, flexibility, and continuous improvement.
Responsibility For Safety
- Ensure manufacturing activities are conducted in compliance with all Health, Safety, Environmental (HSE), and company safety requirements.
- Promote a proactive safety culture by identifying hazards, assessing risks, and driving corrective and preventive actions.
- Participate in the investigation of accidents, incidents, and near-misses, supporting root cause analysis and implementation of preventive measures.
- Ensure manufacturing areas, equipment, and work environments are maintained in accordance with established safety, hygiene, housekeeping, and environmental standards.
- Act as a role model in the application of safe work practices and ensure adherence to all applicable safety procedures.
Work Experience & Skills Required
Essential
- 6+ years of experience in GMP pharmaceutical manufacturing.
- Strong experience in aseptic manufacturing processes.
- Advanced expertise in aseptic filling operations and isolator technology.
- Experience leading deviations, CAPAs, change controls, and investigations.
- Knowledge of FDA, EU GMP, and Annex 1 requirements.
- Experience in manufacturing process improvement and troubleshooting.
- Ability to lead cross-functional initiatives and provide technical guidance to others.
- Fluent English.
Desirable
- Experience supporting regulatory inspections and audits.
- Knowledge of Contamination Control Strategy (CCS).
- Experience with qualification, validation, and technology transfer activities.
- Lean Manufacturing or Six Sigma experience.
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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
