GMP Lab Validation & Compliance Technician

Sartorius AG; Puerto Rico; On-site; USD 60,000 - 95,000; Full time

Benefits offered by this job

Paid vacation and sick leave

14 paid holidays annually

On-site cafeteria

Medical, Dental and Vision insurance

Company retirement plan

On-site occupational health offices

Job summary

Sartorius AG in the United States is seeking a detail-oriented laboratory professional to support qualification, validation quality, and compliance activities within our safety-focused testing environment. You will perform viability tests, bacterial challenges, product integrity analyses, and in-coming material testing, while preparing media and reagents and maintaining SOPs.

Fluent English and strong organizational skills are essential.

Qualifications

• Academic or technical degree in sciences / engineering or similar.
• Minimum 3 years of relevant work experience.
• Experience in the pharmaceutical industry is a plus.
• Good understanding of GMP requirements.
• Familiar with microbiological analysis testing and operating related equipment.
• Self-sufficient, target oriented, well organized and self-motivated work style.
• Good communication and problem-solving skills.
• Experienced with project management and teamwork (ideally in a global environment).
• Team and customer service orientated attitude.
• Proven software skills, e.g. Microsoft Office.

Responsibilities

• Provide qualification / validation quality / compliance support compliant with laboratory safety procedures and requirements of Sartorius Stedim.
• Perform viability, bacterial challenge, product specific integrity and chemical compatibility tests according to Sartorius standard operating procedures and approved validation protocols.
• Perform in-coming material testing.
• Prepare strains, culture media, test solutions and reagents necessary for the performance of all laboratory tests.
• Handle biological indicators, cultures, chemicals and test solutions according to government regulations and company standard operating procedures.
• Complete laboratory data form, interpret results and review.
• Inform laboratory manager of any deviations related to validation protocol execution.
• Initiate and complete any investigations related to deviation of validation protocols or out of specification results.
• Perform necessary cleaning and sanitizing of the laboratory and equipment after testing.
• Check daily monitoring data of laboratory environment and temperature controlled equipment.
• Perform inventory control of consumables and standard reagents to ensure the safety stock.
• Perform qualification, calibration and maintenance of relevant equipment or devices.
• Review validation protocols and validation reports.
• Assist in maintenance of standard operating procedures, including writing and revising.

Skills

GMP knowledge

Project management

Teamwork

Communication skills

Problem solving

Organized work style

Fluent English

Education

Academic or technical degree in sciences / engineering

Tools

Microsoft Office

Job description

Sartorius AG in the United States is seeking a detail-oriented laboratory professional to support qualification, validation quality, and compliance activities within our safety-focused testing environment. You will perform viability tests, bacterial challenges, product integrity analyses, and in-coming material testing, while preparing media and reagents and maintaining SOPs.

Fluent English and strong organizational skills are essential.