Our client in the Dallas Texas area is looking for an experienced
to qualify steam sterilizers (autoclaves) with experience in Kaye validators calibration and programming.
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 (may be requested to work alternate weekends), above average pay and a good work environment. Applicant must be willing to learn new ideas, techniques and systems. Applicant must be willing to commute to clients' manufacturing sites. 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 for steam sterilizers (autoclaves) IQ, OQ and PQs
- Execution of Validation Protocols IQ, OQ and PQs
- Calibration of Thermocouples for Temperature Mapping Studies
- Use of Kaye Digistrip Recorders and Validator Software for Temperature Mapping Studies
- 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
- Validation Engineer wanted with knowledge of validation of steam sterilizers (autoclaves), GMP facilities and cGMP requirements.
- Resource must have experience in Autoclave loads validation, Ellab Sensors and Kaye Validator calibration and programming.
- Applicant must have graduated with an engineering or technical degree from a four-year college or university.
- 2-3 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 Kaye Validator Software is required.
PSC Biotech Corporation is an established validation, regulatory, and compliance company (incorporated in 1996) that specializes in the...