Csv Application Engineer
About Job
With over 50 years of experience in the pharmaceutical industry, Birgi Mefar Group, part of Arcera, continues to evolve by closely following technological developments and investing in innovation. Through its investments and projects in syringe and lyophilization technologies, the Group operates with the vision of becoming a dedicated manufacturing partner for pharmaceutical companies both locally and internationally.
As one of Turkey’s leading contract pharmaceutical manufacturing organizations, Birgi Mefar Group is looking for a qualified “CSV Application Engineer” to join its growing team.
Qualifications
- Graduated from Computer Engineering, Software Engineering, or Automation Engineering departments of universities,
- Strong knowledge of computerized systems and industrial automation processes,
- Minimum 3 years of experience in plant CSV activities and 21 CFR Part 11 compliance projects within manufacturing environments,
- Strong knowledge of GAMP5, EU GMP Annex 11 and Annex 15 guidelines, PLC and HMI systems, and backup processes,
- Experienced in troubleshooting, equipment commissioning, system implementation, and retrospective validation activities,
- Preferably experienced in the pharmaceutical industry (sterile manufacturing),
- Proficient in Microsoft Office applications,
- Excellent written and spoken English skills.
Job Description
- Responsible for CSV remediation and compliance activities related to computerized systems and equipment used in sterile manufacturing operations,
- Planning and implementing corrective, preventive, and improvement actions to ensure compliance with GMP and CSV requirements,
- Preparing, reviewing, and executing CSV documentation, including URS, FS/DS, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, and validation reports,
- Performing retrospective validation and gap assessment/remediation activities for computerized systems,
- Supporting lifecycle management activities, including periodic review, change control, deviation management, CAPA follow-up, backup verification, and audit trail review,
- Applying risk-based decision-making principles in validation and compliance activities,
- Providing technical and compliance support during customer and regulatory authority inspections,
- Coordinating with third-party vendors and service providers involved in GMP-regulated CSV and automation projects,
- Collaborating with QA, Engineering, Production, and IT teams to ensure sustainable CSV compliance,
- Defining investment, improvement, and revision needs for current and future GMP-CSV compliance and industrial automation requirements,
- Ensuring all validation activities are performed in accordance with applicable GMP regulations, internal procedures, and global data integrity expectations.
Preferred Candidate
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Şirket Hakkında
Founded in 1985 as a joint-venture between Birgi Sanayi A.Ş. and Pharma Hameln GmbH of Hameln, Germany, Mefar is specialized in toll manufacturing of small- and medium- volume parenteral solutions in ampoules, vials and bottles, as per customer's specifications; as well as sterile solutions in plastic containers using blow-fill-seal technology. GMP certified by the german health authorities since 1997, the plant is equipped with fully automatic production lines, and functions as an integral part of the ampoule- and vial-production facilities of Birgi Sanayi A.Ş. Thus it has been possible to eliminate several stages of packing, transportation and storage as possible sources of contamination.
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