SRG Life Sciences offers the industry flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services in the clinical, manufacturing, medical and scientific fields. Through our innovative approach and proprietary database of over one million professionals, SRG Life Sciences offers ready access to the talents that drive today's rapid paced and competitive landscape. Additionally, SRG Life Sciences has a proven track record of placing cross-functional roles such as Information Technology, Accounting and Finance, Engineering, Professional and Government Services for our Life Sciences clients.
Title: Validation Specialist
Location: Boston, MA
Industry: Pharmaceutical/Medical Device/Biotechnology
Salary: $40.00-$45.00/hr. plus overtime (hourly, although direct hire position)
Employment Type: Direct hire with benefits
Travel Requirements: Minimal travel within Boston area (various client support)
Environment: This client services national pharmaceutical, biotech, medical device and related industries specializing in various validation efforts from process, equipment, computer, utilities, facilities in addition to quality measures and regulatory affairs efforts.
- 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, analyze, write Cleaning, Process, Computer validation protocols according to internal and external requirements.
- 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
- Minimum 5 years working industry knowledge as a Validation Engineer or Specialist within pharmaceutical, medical device, biotechnology or related fields
- Experience in writing and execution of IQ, OQ, and PQ forms and protocols for GMP Utilities, Manufacturing and Laboratory Equipment, Systems and Software.
- Both facilities and manufacturing, lab equipment qualification is highly desired. For instance; HVAC, Chillers/Broilers, Fermentation Systems, Stability Chambers, Tablet Press, Encapsulators, Bioreactors, Blenders, etc.
- Experience with Cleaning, Process, Computer System, Methods, and other validation activities and processes
- Experience with Risk-Based Approach to Commissioning and Qualification is beneficial.
- Excellent communication skills, multi-task and able to work in a fast-paced environment
- Ability to think critically and demonstrate troubleshooting and problem-solving skills
- 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.
Search words: Engineer, Scientist, Validation, IQ/OQ/PQ, Process Engineer, cleaning validation, computer validation, QA, quality assurance