Computerized systems engineer in biopharma - imunobiologichna farmacevtichna kompaniya

Biopharma is a Ukrainian biotechnological company specializing in the production of medicinal products from donated human blood plasma. For more than 125 years, we've been developing innovative medicines that save millions of lives and restore them to health. We adhere to GMP standards in our business and are strict about our standards for the quality of our products. The long-term trust of our patients inspires us to new developments and achievements for a better life for Ukrainians!

Opportunities for students

We are actively considering candidates studying in the last courses of the below-mentioned specialties.
We offer practice or internship with the possibility of further official employment.

Requirements:

Higher technical education in one of the fields:

• Software engineering

• Computer science

• Computer engineering

• System analysis

• Information systems and technologies

• Cyber security

• Automation and computer-integrated technologies

• Metrology and information and measurement equipment

• Electronics

• Telecommunications and radio engineering

• Pharmaceutical / industrial pharmacy

  details.

• Discipline in keeping logs and registers according to SOP.

Knowledge required Computer literacy

• Windows: local users/groups, NTFS/SMB rights, Office package.

• Networks: basic knowledge of IP/DNS, working with the scheduler tasks.

• Backups: understanding the principles of full and incremental copying, verification of recovery to a test location.

• Scripting: basic level of PowerShell or Batch (ability to read and edit ready-made scripts).

• Access security: principles of least necessary privileges (Least Privilege), separation of duties (SoD), blocking of accounts records.

Documentation

• Ability to work according to instructions.

• Filling account registers, roles and backup logs.

Languages

• Ukrainian - fluent.

• English - at least B1 level (reading technical manuals, SOP, correspondence).

Functional responsibilities

• Managing user accounts, performing backups, testing, basic analysis of computerized system logs.

• Maintaining and updating account registers, backup logs, backup inspection reports, archives and accounting records.

• Preparation of reports for internal and external audits.

• Periodic review of the status of computerized systems.

Possessing the following skills and knowledge will be an advantage:

• Knowledge of the basics of GAMP 5 (v2), EU GMP Annex 11, Data Integrity (ALCOA+), basic understanding of 21 CFR Part 11.

• Experience of working with Change Control procedures, access review.

Management access

• AD/LDAP, group policies (GPO), lockout settings, session timeout, NTP.

• Building and maintenance of access matrixes (RBAC), separation of duties control (SoD).

Backups and infrastructure

• Knowledge of 3-2-1 policies, RPO/RTO, test planning restorations.

• Working with MS SQL Server: types of backups (full/dif/incremental), integrity check, restoration to a test bench, basic administration.

Information security

• Fundamentals of ISO 27001, IEC 62443.

• Hardening of servers and workstations, control updates, use of EDR/antiviruses, policies for working with external media.

Experience

• From 2 to 5 years in relevant roles:
  IT administrator, ACS engineer, CSV/DI coordinator, LIMS or CDS administrator.

Working conditions:

• Official registration, work in a friendly young team of professionals
• Place of work - Bila Tserkva, 37V Kyivska Street
• Work schedule - 5/2 (8:00-17:00)
• Competitive salary level
• Opportunities for growth