Senior Validation Engineer (Process & Cleaning)

Location: Greater Birmingham, AL Duration: 12 Months and extendable Experiance: 6-8 Years Job Summary We are seeking a Senior Validation Engineer to support Process & Cleaning validation activities for a regulated manufacturing site. The primary focus will be process validation for manufacturing operations such as compounding, mixing, bulk preparation, holding, transfer, filling, and packaging. The role will also support cleaning validation activities for product-contact equipment, including CIP skids, mixing vessels, transfer lines, holding tanks, filling equipment, and associated manufacturing systems. Key Responsibilities Author, review, and execute process validation protocols, process qualification documentation, validation batch records, and process validation summary reports.Support process validation activities for manufacturing operations including compounding, mixing, heating/cooling, bulk hold, transfer, filling, packaging, and related production steps.Review manufacturing batch records, process parameters, equipment settings, in-process checks, yield data, hold times, sampling results, and execution evidence to confirm process consistency and compliance with approved acceptance criteria.Support validation of CIP skids and cleaning processes for product-contact equipment, including cleaning cycle review, recipe parameters, spray coverage considerations, rinse steps, detergent concentration, temperature, flow rate, conductivity, and cleaning cycle completion records.Develop or review cleaning validation documentation, including cleaning protocols, swab/rinse sampling plans, dirty hold time, clean hold time, equipment grouping, worst-case product selection, residue limits, acceptance criteria, and cleaning validation summary reports.Coordinate swab and rinse sampling activities with Manufacturing, QA, QC, Validation, and laboratory teams to support cleaning validation execution and sample testing.Review cleaning records, CIP cycle reports, rinse sample results, swab sample results, TOC or residue data, microbiological results, and related documentation to confirm cleaning effectiveness.Support process qualification and continued process verification activities, including data compilation, trend review, process monitoring, and identification of process variability or recurring manufacturing issues.Assist with review of critical process parameters, critical quality attributes, process controls, sampling requirements, and acceptance criteria for process and cleaning validation activities.Investigate deviations, discrepancies, failed acceptance criteria, cleaning failures, CIP cycle interruptions, batch execution issues, or documentation gaps identified during validation activities.Prepare validation reports and technical summaries documenting execution results, deviations, data review, conclusions, and recommendations for continued process and cleaning control.Support change controls, risk assessments, impact assessments, CAPA actions, SOP updates, and validation lifecycle documentation related to manufacturing processes, CIP systems, and cleaning validation. Required Qualifications Bachelor s degree in Engineering, Life Sciences, Chemistry, Pharmaceutical Sciences, or related technical field.Experience supporting process validation in a GMP-regulated pharmaceutical, biotech, consumer health, cosmetic, or life sciences manufacturing environment.Experience with process validation activities such as protocol execution, validation batch support, batch record review, process data review, deviation handling, and validation report preparation.Working knowledge of cleaning validation for product-contact equipment, including CIP skids, swab/rinse sampling, cleaning cycle parameters, dirty hold time, clean hold time, residue limits, and acceptance criteria.Ability to review manufacturing records, cleaning records, CIP cycle reports, process parameters, in-process data, sampling results, and validation execution evidence.Familiarity with GMP, GDP, data integrity, deviation/CAPA, change control, risk assessment, and validation documentation practices.Strong technical writing, documentation review, problem-solving, and cross-functional communication skills. Preferred Qualifications Experience with topical, semi-solid, liquid, cream, balm, wax-based, cosmetic, personal care, or related manufacturing processes.Experience with mixing vessels, holding tanks, transfer lines, CIP skids, pumps, hoses, filling equipment, packaging lines, utilities, and product-contact equipment.Experience preparing process validation reports, cleaning validation reports, technical assessments, validation summary reports, and manufacturing data summaries.Familiarity with TOC testing, conductivity, pH, visual inspection, detergent residue testing, bioburden, endotoxin, or other analytical/microbiological methods used to support cleaning validation.Experience using electronic quality or documentation systems such as Veeva, TrackWise, MasterControl, Kneat, ValGenesis, or similar platforms.