Sterility Assurance Specialist

Aenova Group; Latina; On-site; EUR 30,000 - 40,000; Full time

Job summary

Haupt Pharma Latina S.r.l. in Latina, Italy, is seeking an experienced professional to support Sterility Assurance and aseptic processing within sterile manufacturing.

You will collaborate across Production, Engineering, MS&T, Validation and QA to minimize microbiological risks. The role requires a scientific degree and at least 3 years in Sterility Assurance, Microbiology or Quality in a sterile pharmaceutical environment, with strong GMP knowledge and English skills.

Qualifications

• University degree in a scientific discipline (Biology, Biotechnology, Pharmaceutical Chemistry and Technology, Pharmacy, Chemistry or related fields); Master’s degree preferred.
• At least 3 years of relevant experience in Sterility Assurance, Microbiology, Quality or Manufacturing within a sterile pharmaceutical environment.
• Good knowledge of GMP and EU GMP Annex 1; knowledge of FDA requirements is considered an advantage.
• Experience or solid knowledge of aseptic processing, APS and contamination control principles.
• Knowledge of Contamination Control Strategy principles.
• Good written and spoken English.
• Strong analytical, communication and cross-functional collaboration skills.
• Experience with cleanroom qualification, technology transfer, environmental monitoring and electronic quality systems is considered a plus.

Responsibilities

• Support and oversee Sterility Assurance and aseptic processing activities within sterile manufacturing areas, including APS.
• Collaborate with Production, Engineering & Maintenance, MS&T, Validation and Quality Assurance to identify, assess and mitigate microbiological contamination risks.
• Support the definition and implementation of contamination control requirements for sterile operations, qualification and validation activities.
• Support deviation investigations, root cause analysis and CAPA definition related to sterility assurance and microbiological events.
• Support the implementation, maintenance and periodic review of the Contamination Control Strategy (CCS).
• Provide Sterility Assurance expertise during regulatory inspections, customer audits and corporate assessments.
• Support technology transfer, qualification/validation and continuous improvement projects within sterile manufacturing.

Skills

GMP knowledge

Aseptic processing

Analytical skills

Cross-functional collaboration

English proficiency

Education

University degree in a scientific discipline

Tools

Environmental monitoring

Job description

for the site Borgo San Michele LT, Italy

Would you like to make a valuable contribution to the health of patients? And do something really meaningful on your own responsibility? Then we look forward to hearing from you! Excellence beyond manufacturing - that's what we stand for as Aenova, one of the world's leading contract manufacturers and developers for the pharmaceutical industry with 4,000 employees at 15 sites. Latina is a leading centre of excellence in sterile liquid production, with a strategic investment plan to become one of Europe's foremost hubs.

Your Key Responsibilities

• Support and oversee Sterility Assurance and aseptic processing activities within sterile manufacturing areas, including APS.
• Collaborate with Production, Engineering & Maintenance, MS&T, Validation and Quality Assurance to identify, assess and mitigate microbiological contamination risks.
• Support the definition and implementation of contamination control requirements for sterile operations, qualification and validation activities.
• Support deviation investigations, root cause analysis and CAPA definition related to sterility assurance and microbiological events.
• Support the implementation, maintenance and periodic review of the Contamination Control Strategy (CCS).
• Provide Sterility Assurance expertise during regulatory inspections, customer audits and corporate assessments.
• Support technology transfer, qualification/validation and continuous improvement projects within sterile manufacturing.

Your profile

• University degree in a scientific discipline (Biology, Biotechnology, Pharmaceutical Chemistry and Technology, Pharmacy, Chemistry or related fields); Master’s degree preferred.
• At least 3 years of relevant experience in Sterility Assurance, Microbiology, Quality or Manufacturing within a sterile pharmaceutical environment.
• Good knowledge of GMP and EU GMP Annex 1; knowledge of FDA requirements is considered an advantage.
• Experience or solid knowledge of aseptic processing, APS and contamination control principles.
• Knowledge of Contamination Control Strategy principles.
• Good written and spoken English.
• Strong analytical, communication and cross-functional collaboration skills.
• Experience with cleanroom qualification, technology transfer, environmental monitoring and electronic quality systems is considered a plus.

Annual salary range: EUR 30.000 - 40.000

Your motivation

Are you looking for new challenges in a highly competitive environment? And you want to tackle them creatively and on your own responsibility? Do you prefer a "get-it-done" culture and think in terms of solutions rather than problems?

Haupt Pharma Latina S.r.l.

• Member of the Aenova Group
• Strada Statale 156 dei Monti Lepini
• 04100 Borgo San Michele LT, Italy