Validation Engineer required for PSC Biotech Cork and Dublin. Permanent positions
PSC is a leading life sciences consulting, engineer contracting, and IT services company. For over 10 years we have been engaged in providing project, process, IT, engineering and validation support to top-tier pharmaceutical and biotech companies. Currently, we are looking for Validation Engineers to support our clients in Dublin and Cork.
Applicant will be working in a biotech/pharmaceutical environment as a consultant/contractor for various clients of PSC. He/she will be working closely with client's employees on various projects and various GMP facilities to help client with validation issues. Work constitutes flexible hours, above average pay and a good work environment. Applicant must be willing to learn new ideas, techniques and systems. On-site training will be provided. Work is interesting and involves the ability to deal with and interpret technical information for the benefit of the client. Applicant must be knowledgeable in dealing with and keeping proprietary information confidential.
- Writing of Validation Protocols such as IQ, OQ and PQs
- Execution of Validation Protocols such as IQ, OQ and PQs
- Calculation and interpretation of data for Equipment Validation Studies
- Excel Spreadsheet Generation and Summary Report Writing for PQ studies
- Review and modify Standard Operating Procedures (SOPs)
- Generate test procedures to validate new or previously unvalidated equipment/processes
- Participate in and conduct any or all of the following types of validation:
- Cleaning Validation
- Process Validation
- Computer Validation
- Equipment Validation
- SIP/CIP Validation
- Risk Assessments
- Required knowledge of GMP facilities and cGMP requirements.
- Applicant must have graduated with an engineering or technical degree from a four-year college or university.
- 2-5 years of work experience in a regulated industry (preferably FDA-regulated biotech/pharmaceutical) industry.
- Applicant must be knowledgeable about regulatory/compliance/validation issues, be self-motivated, intelligent and reliable.
- Knowledge of PC computer OS (typically Windows), knowledge of Word and excel are mandatory.
- Must have strong written and oral communication skills
- Experience in writing technical documents, especially compliance and/or Validation/quality assurance documents and protocols will be desired.
- In addition, applicant will be required to demonstrate experience and skill in writing technical reports.
- Knowledge in the use of Kaye Instruments' Digistrip Recorders and Validator Software will be advantageous.
- Applicant must also be willing to perform more sophisticated/complicated types of validation work.