Validation Specialist for Biotech and Pharma Industry Job at ProQuality Network
Job description
ProQuality Network is a pharmaceutical consulting firm of industry leaders that provides quality services to the Life Sciences industries.
We are currently seeking Validations Specialist to provide services at a customer site in Juncos, PR.
Requirements:
- Development, execution, and reports for Commissioning and Qualification documentation related to GXP Equipment and Utilities in new buildings for sterile manufacturing facilities.
- Previous experience with AHU, Water Systems Qualification and sterile filling units such as isolators/RABS technology.
- Prepare protocols, coordinate with team members execution and activities
- Develop reports, investigate, and resolve deviations.
- Develop SOPs
- Develop SDLC documentation as required (URS, DS, FS, FAT, etc)
- Risk Assessments if required
- Cleaning and process validation experience
Candidates must be able to work on-site.
Knowledge/Skills:
- Bachelor's Degree in sciences, engineering, computer systems or related fields preferred.
- 2+years of experience with writing equipment validation / qualification protocols and their corresponding summary reports / deviation reports in pharma manufacturing companies.
- Able to communicate effectively in written and verbal forms (in English).
- Able to work in a multidisciplinary team to meet project deadlines.
- Be a proactive team member that communicates project progress and obstacles in a respectful and timely manner so as to keep project on track and ensure success.
- Excellent technical writing and documentation skills following cGMPs
Job Type: Full-time
Schedule:
- 8 hour shift
Shift availability:
- Day Shift (Preferred)
Job Types: Full-time, Contract
Benefits:
- Health insurance
- Paid time off
Schedule:
- 8 hour shift
Ability to commute/relocate:
- Juncos, PR 00777: Reliably commute or planning to relocate before starting work (Required)
Experience:
- Manufacturing: 2 years (Preferred)
Work Location: Hybrid remote in Juncos, PR 00777
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