Gannet BioChem ยท 3 weeks ago
Validation Engineer II (2026-004-208)
Huntsville, AL
Full-time
Onsite
Senior Level
5+ years expGannet BioChem is seeking a Validation Engineer II to support equipment qualification and process validation. The role involves preparing and reviewing protocols, collaborating with various departments, and providing training on validation policies and procedures.
BiopharmaChemicalManufacturing
Responsibilities
Performs a variety of activities in support of equipment qualification and process validation including preparing and reviewing protocols and final reports, representing validation on project teams and preparing validation change control requests and revalidation assessments
Interfaces with peers in groups such as, Engineering, Process Development and Manufacturing to ensure that the design, implementation and qualification of equipment, systems and processes is conducted according to established quality standards through lifecycle management
Uses skills as a seasoned, experienced professional with a full understanding of industry practices and company policies and procedures
Resolves a wide range of issues in imaginative as well as practical ways
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors
Demonstrates good judgment in selecting methods and techniques for obtaining solutions
Interacts with senior internal and external personnel
Provides general support to the organization to meet department goals and objectives
Participates on project teams requiring validation support
Provides training to company and contracted personnel on validation policies and procedures
Participates in the preparation or review of protocols and reports supporting the validation of equipment, systems and processes
Executes on validation protocols
Collects, compiles and reviews data in supports of validation studies
Supports validation change control activities and provides support for revalidation assessments of equipment, systems and processes
Receives minimal supervision on assigned tasks and projects
Qualification
Required
Requires a Bachelors degree in an engineering discipline. Equivalent experience may be accepted
A minimum of 5 years relevant work experience is required
A minimum of 2 years validation experience is required
Must be able to demonstrate knowledge of validation principles including user requirements, functional specifications, commissioning, IQ, OQ, PQ and process validation
A thorough knowledge of cGMP and regulatory requirements for validation is required
A working knowledge of utilities and general production systems used in non-sterile pharmaceutical manufacturing is required
Strong word processing and spreadsheet skills are required
Good communication skills both oral and written are required
Must be able to demonstrate excellent customer service skills
Strong attention to detail regarding documentation is a must
Must be well organized, and willing to work as part of a team
Must be able to pass pre-employment drug screening and background check for employment consideration
Employees must be able to lift or handle objects greater than 25 pounds to perform certain duties essential to the job function
Employees may be required to perform tasks essential to the job function in areas that require the use of hearing protection devices
Employees must be able to gain access to elevated work surfaces via vertical ladders or stairs to perform tasks essential to the job function
Company
Gannet BioChem
Gannet BioChem is a biotechnology company that manufactures biopharmaceutical and therapeutic products.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Nicholas Shackley
Chief Executive Officer
Bob Rodebaugh
Vice President of Technology
Recent News
2025-12-18
2025-10-14
Company data provided by crunchbase