Clinical Research Associate Ii

Parexel; Meira; On-site; EUR 26,000 - 36,000; Full time

Job summary

PCI Pharma Services in Leon, Spain, is seeking a Level II Production Operator to execute aseptic manufacturing and batch activities. You will follow SOPs, ensure compliance with cGMP and regulatory guidelines, and support continuous improvement while maintaining production records.

The role requires hands-on production work, collaboration with cross-functional teams, and adherence to safety and quality standards in a fast-paced environment.

Qualifications

• Experience in aseptic manufacturing and sterile processing.
• Ability to follow SOPs and regulatory guidelines (AEMPS, FDA) and maintain quality.
• Strong teamwork and communication in a production environment.

Responsibilities

• Operate production equipment following SOPs and GMP guidelines.
• Maintain cleanliness and order of production areas.
• Support preparation and dispensing of materials and batches.
• Participate in qualification activities for production equipment.
• Document batch records and notes accurately.

Skills

Aseptic manufacturing

Batch production

Regulatory compliance

Education

High school diploma or equivalent

Tools

Autoclave operation

Sterile packing

Job description

Leon, Spain

Full time

JR

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 II Production Operator (Technician II) executes and runs autonomously the batch aseptic manufacturing activities, billable activities, or continuous improvement activities required in the production department, following instructions and standard operating procedures in accordance with the AEMPS, FDA, and other regulatory agencies under supervision. In addition, they must ensure the execution of production plans, following all company safety guidelines. A high level of detail is required due to the complexity of the activities to be performed. The minimum training time for this position is normally 3 years to develop the full work.

• 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.
• 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, 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 cGMP regulations.
• Handle pallet trucks for the movement of goods.
• 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.
• Operate production equipment following the guidelines indicated in the work procedures
• Supports the manufacture of the different products following the instructions of the manufacturing guides and complying with cGMP regulations.
• Supports the activities of the qualification of production equipments.
• Demonstrate a general knowledge of aseptic techniques (maintaining difficult body posture and movement during long periods of time).
• Successful participation in the gowning qualification as well as the media fill plan.
• Leads 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 classified and non classifies clean production rooms.
• Leads the activities of set up grade D/C ( ex. activities of the processes of preparation of autoclave cycles and assembly of installations, perform cleaning of production equipment.).
• Supports the activities of set up grade A/B
• Leads the activities of formulation processes grade C.
• Supports the activities of formulation processes grade A/B.
• Leads the activities of filtration processes grade C.
• Supports the activities of filtration processes grade AB.
• Supports filling activities.
• Supports the activities of sip execution of sterilizable equipment.
• Trains Technicians level I

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

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._

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled