Manufacturing Operator (Manufacturing Tech. I)

Pci Pharma Services; Málaga; Presencial; EUR 21.000 - 32.000; Jornada completa

Descripción de la vacante

PCI Pharma Services is seeking a Manufacturing Operator (Manufacturing Tech. I) in Málaga, Spain. The role involves learning and executing aseptic batch manufacturing activities under supervision, following AEMPS, FDA, and other regulations while ensuring production plans are met.

You will participate in safety programs, collaborate with teammates, and help prepare for inspections, while maintaining accurate batch records and documents.

Formación

• Must follow SOPs and cGMP regulations.
• Ability to operate production equipment safely.
• Maintain cleanliness and order of production areas.
• Collaborate with cross-functional teams and identify process improvements.
• Complete batch records and production documentation.

Responsabilidades

• Operate production equipment following manufacturing guides.
• Disinfect, clean, and prepare materials for manufacturing.
• Support aseptic manufacturing and media fill activities.
• Assist in investigations of quality events and deviations.
• Ensure stock levels of consumables and equipment are adequate.

Conocimientos

Aseptic technique

Equipment operation

Safety compliance

Documentation

Team collaboration

Herramientas

Pallet trucks

Descripción del empleo

Manufacturing Operator (Manufacturing Tech. I)

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.

The Level I Production Operator (Technician I) learns and executes the aseptic batch manufacturing activities, billable activities or continuous improvement that are required in the production department, following the instructions and standard operating procedures in accordance with the AEMPS, FDA and other regulatory agencies under supervision. Ensuring the execution of production plans, while following all the company's safety guidelines.

• Comply with manufacturing area safety regulations and work practices in accordance with all company Health, Safety and Environmental programs.
• Work as a team, being approachable, practical, motivating, able to support and inspire your co-workers.
• Participation in the "Quarterly conversation"
• Comply with the schedule by following the prioritization instructions of their senior managers to ensure compliance with the schedules together with the department head.
• Collaborate in the identification of opportunities for continuous improvement to improve processes and practices.
• Comply with the requirements of cGMP, AEMPS, FDA and other regulatory agencies that have been implemented in the plant, as well as with the department's objectives and corporate quality standards.
• Collaborate and participate in preparing for inspections by regulatory agencies or clients.
• Participate in the control of the stock of plant consumables, to guarantee their availability.
• Collaborate in the investigations of the different quality events (deviations, CAPAs, change controls...).
• Inform the direct manager when anomalies are detected in the operation of equipment, as well as human errors, both their own and those of the team's personnel, in order to ensure the quality of the product manufactured.
• Inform the direct manager if safety equipment or human resources needs are identified.
• Collaborate in teamwork with other departments if required.
• Take care of and ensure the proper functioning of the equipment
• Operate production equipment following the guidelines indicated in the work procedures
• Participate in the manufacture of the different products following the indications of the Manufacturing Guides and complying with GMP regulations.
• Handle pallet trucks for the movement of goods.
• Demonstrate a general knowledge of aseptic techniques
• Successful participation in the gowning qualification as well as the Media Fill plan
• Review relevant SOPs and production lot records, as needed.
• Complete and maintain documentation related to assigned work, including notebooks, batch records, etc
• Comply with and maintain cleanliness and order of production areas in accordance with appropriate standard operating procedures.
• Perform the activities of dispensing and preparing materials to be used in the activities of the department.
• Perform the sanitization of materials prior to their introduction into the manufacturing areas
• Disinfect and clean production rooms
• Supports the activities of formulation processes
• Supports the activities of the activities of filtration processes
• Supports the activities of the processes of preparation of autoclave cycles and assembly of installations
• Supports the activities of the qualification of Production equipments.
• Operate production equipment following the guidelines indicated in the work procedures
• Perform cleaning of production equipment
• Supports the manufacture of the different products following the indications of the Manufacturing Guides and complying with GMP regulations.
• Supports the activities of SIP execution of sterilizable equipment

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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.