Upstream operario

mAbxience; León; On-site; EUR 26,000 - 36,000; Full time

Job summary

mAbxience in Spain is seeking a Cell Culture USP Specialist to perform cell culture activities according to process specs and quality standards, under GMP guidelines.

You will document activities in logbooks and BRs, prepare equipment, support sterilization and cleaning, install and qualify equipment, and contribute to continuous improvement and deviation investigations.

Qualifications

• Experience with GMP and SHE regulations.
• Cell culture knowledge and hands-on experience preferred.
• Strong documentation and record-keeping skills.

Responsibilities

• Execute the cell culture activities, according to process specifications and quality standards.
• Write SOPs related to the equipment and activities of USP department.
• Write batch records.
• Prepare the production equipment prior to its use and after it (cleaning, inactivation, etc.).
• Register all the productive activities in logbooks, batch records (BRs) or other documents, according to the Company’s quality procedures.
• Prepare culture means and process, filtering and sterilization solutions.
• Provide support in preparation activities, reconditioning and materials sterilization.
• Install and qualify equipment and support its maintenance, calibration and requalification.
• Participate and promote improvements in the productive processes, records and activities of the Company, encouraging the continuous improvement.
• Provide information and support in researches related to quality deviations and participate in the follow up of the subsequent implementation of corrective and preventive measures.

Skills

GMP Knowledge

SHE Regulations

Cell Culture Experience

Attention to detail

Quality documentation

Education

Degree in Pharmacy or similar

Job description

Execute UpStream (USP) activities in the Cell Culture area of the production department, following operational procedures and GMP regulations.

Specific Responsibilities

• Execute the cell culture activities, according to process specifications and quality standards.
• Write SOPs related to the equipment and activities of USP department.
• Write batch records.
• Prepare the production equipment prior to its use and after it (cleaning, inactivation, etc.).
• Register all the productive activities in logbooks, batch records (BRs) or other documents, according to the Company’s quality procedures.
• Prepare culture means and process, filtering and sterilization solutions.
• Provide support in preparation activities, reconditioning and materials sterilization.
• Install and qualify equipment and support its maintenance, calibration and requalification.
• Participate and promote improvements in the productive processes, records and activities of the Company, encouraging the continuous improvement.
• Provide information and support in researches related to quality deviations and participate in the follow up of the subsequent implementation of corrective and preventive measures.

Requirements and personal skills

• Education: Degree in Pharmacy or similar.
• Languages: Fluent Spanish and English, knowledge of other languages will be an asset.
• Experience (years/area): +2 years of experience in a similar position.
• Specific Knowledge: USP activities, GMP and SHE regulations.
• Work shifts: 2 work shifts Morning - Evening.
• Personal skills: Attention to detail, accuracy and reliability.

At mAbxience, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.