Validation Engineer
A growing Pharmaceutical company in Tampa Bay, FL is looking for a Validation Engineer to join the team for a Permanent job opportunity. Must have HVAC/Utilities/Facilities Validation experience within Pharmaceutical or Medical Device industries.
Validation Engineer Responsibilities:
- Process validation of commercial manufacturing processes. This includes writing, review and execution of process validation protocols.
- Recommend, specify and order cGMP manufacturing equipment which includes installation, setup and qualification.
- Inspect, plan and evaluate use of space and facilities. Analyze HVAC systems, boilers, chillers, refrigeration, computer network wiring, lighting and other utilities.
- Perform audits as required to support facility planning. Oversee the coordination of building space allocation, layout and communication services.
- Oversee and direct maintenance personnel and workers engaged in equipment installation, facilities equipment repair and preventative maintenance. Formulate and coordinate program specifications, requirements for proposals and contracts and associated documents.
- Writing, execution and review of qualification protocols for equipment and facilities.
- Provide technical support to all GMP Manufacturing processes
- Develop manufacturing processes in conjunction with internal Formulation Development group, client or combination thereof, to enhance and improve the manufacture of GMP drug products. Attend applicable meetings in support of these projects. Recommend, specify and order equipment and parts in support of specific projects.
- Write Master Batch Records and review executed batch records
- Write, review and approve Standard Operating Procedures (SOPs), specifications, and other procedures as required
Qualifications:
- BS in Chemical, Mechanical or Manufacturing Engineering
- Experience with IQ, OQ, PQ of pharmaceutical manufacturing equipment
- 4 or more years of Pharmaceutical/Medical Device Experience
- Experience with Facilities and Utilities (HVAC, Refrigeration, Boilers, Chillers, Air etc)
- Strong Technical Writing Ability
To apply, please send your resume to rebecca.howe@srg-us.com
