Manufacturing Technician IV

PCI TRGR Penn Pharmaceutical Services Ltd; León; On-site; EUR 32,000 - 52,000; Full time

Job summary

PCI Pharma Services is hiring a Level VI Production Operator (Technician IV) to execute and lead aseptic manufacturing activities in accordance with cGMP and regulatory standards. The role requires high attention to detail and the ability to manage production plans and safety guidelines.

The candidate will review batch records, ensure equipment functionality, and support continuous improvement while training junior technicians and serving as shift supervisor backup as needed.

Qualifications

• Minimum five years of training is expected for Level VI Production Operator (Technician IV).
• Solid understanding of cGMP, AEMPS, FDA and other regulatory standards.

Responsibilities

• Comply with manufacturing area safety regulations and company health, safety and environmental programs.
• Lead complex aseptic manufacturing activities and supervision of production processes.
• Review batch records and production lot documentation for accuracy and compliance.
• Maintain proper equipment function and participate in equipment qualification activities.
• Prepare and manage materials, and train Level III technicians; act as shift supervisor backup.

Job description

Level VI Production Operator (Technician IV)

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 VI Production Operator (Technician IV) executes, runs autonomously, advises and leads complex activities of aseptic manufacturing of batches, 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 is normally 5 years.

• 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 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 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…).
• Leads the activities of set up grade A/B
• Leads the activities of formulation processes grade C.
• Leads the activities of formulation processes grade A/B.
• Leads the activities of the activities of filtration processes grade C.
• Leads of the activities of filtration processes grade AB.
• Leads filling activities.
• Leads the activities of sip execution of sterilizable equipment.
• Leads the activities of sip execution of complex sterilizable equipment.
• Trains technicians level III
• Shift supervisor back-up

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.

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.