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Title: Validation Specialist
Location: Largo/Clearwater Area, Florida
Industry: Pharmaceutical and Chemical Manufacturing
Shifts Available: Monday-Friday, 8am-5pm (expect over-time, up to 10 hour days)
Salary: $50,000-$65,000 depending on experience
Employment Type: Direct hire
Environment: This client innovates, formulates and creates consumer brands. They serve companies in pharmaceutical, cosmetic, personal care and chemical applications. Using state-of-the-art equipment, their team of experts work to ensure high quality. Highly differentiated products are brought to market with exceptional customer service. Isn t this the type of company you want to work for?
Support process validation activities for dermal products. Complete qualification and requalification activities for equipment used to manufacture these products. One will be supporting cleaning validation, process writing and technical transfer. We are looking for one with experience within packaging.
- Perform field/site activities pertinent to FATs and SATs ( Factory Acceptance Testing and Site Acceptance Testing), vendor start-up testing, and execution of commissioning, qualification and validation protocols.
- Author validation documentation including, but not limited to, Installation, Operational and Performance Qualification protocols and reports, Process Validation protocols and reports, Cleaning Validation protocols and reports, and Protocol Discrepancies and Addenda; IQ/OQ/PQ
- Prepare Cleaning and Process validation protocols according to internal and external requirements.
- Execute qualification, cleaning and process validation tests in accordance with approved protocols, procedures and guidelines.
- Analyze cleaning and process validation test data to determine systems have met validation criteria.
- Write process and cleaning validation final reports that offer conclusions based on test results.
- Document testing results in validation/qualification protocols per protocol requirements; obtain samples to be analyzed per qualification/validation protocol requirements.
- Assure that all validation activities are performed in compliance with approved validation/qualification protocols, standard operating procedures (SOPs), and current regulatory requirements/guidelines.
- Has proficiency in more than one functional area (Equipment Qualification, Process validation, etc.)
- At the discretion of VP or Director of Engineering, approve validation protocols in areas where the specialist is deemed a subject matter expert
- Keep current on regulatory and quality requirements for manufacturing, qualification, and validation activities.
- Bachelor s degree in Engineering or Science discipline
- 3 years working knowledge of chemical manufacturing industry
- Minimum 3 years of industry experience in Biotech, Pharmaceutical, Medical Device Design, Chemical, Validation, or QA.
- Experience in writing and execution of IQ, OQ, and PQ forms and protocols for GMP Utilities, Equipment, Systems, and Software.
- Experience in GMP/Validation with knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and regulatory requirements
- Experience with Cleaning, Process, Computer System, Methods, and other validation activities and processes, beneficial.
- Experience with Risk-Based Approach to Commissioning and Qualification is beneficial.
- Experience within packaging validation
- Excellent communication skills, multi-task and able to work in a fast paced environment
- Must be able to work extended hours on evenings and weekends as required.
- Must be capable of detailed record keeping and communicating results to others.
- Must be able to lift up to 20 pounds on a regular basis.
- Must be able to wear personal protection equipment which includes gloves and respirator, when required.
Search words: Engineer, Scientist, validation, IQ/OQ/PQ, packaging, process engineer, cleaning validation, computer validation, QA, quality assurance, technical transfer, chemical