Strong knowledge of automated and semi-automated device assembly, validation, and troubleshooting Experience in GMP-Regulated..., qualification, and validation activities for GMP equipment, including ownership of the sites master validation plan. Support...
, Qualification and Validation (CQV) process for applicable automated systems including Automated warehouse with ASRS (Automated... and adoption Strong project management and communication skills Strong knowledge of cGMP and validation processes. Experience...
, Qualification and Validation. Collaborate with Quality, Mfg Managers, Plant Engineering, Process Development and Regulatory... with Commissioning and Qualification, New Product Introduction, Cleaning Validation, and Process Performance Qualification Ability...
, and improve the facility's Environmental Monitoring (EM) Program, including SOPs, design, and program validation. Provide...
, maintenance records, and validation reports. Respond promptly to equipment breakdowns, emergencies, and production interruptions...
, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical, and process... and other regulatory agencies. Support cGMP validation of equipment and processes. Complete advanced maintenance activities or operate...
Analytical chemistry in a manufacturing environment (Preferred) 1-3 years Method development and validation (Preferred... (Low proficiency) Instrumentation Calibration (Low proficiency) Method Validation (Low proficiency) Chemical Handling...
, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system... in the area of final drug product operations Knowledge of pharmaceutical/biotech processes Familiarity with validation...
, validation, electrical and process automation issues. Assist during regulatory agency inspections. Provide technical support...
, and aseptic simulation media fill validation. Strong communication skills with the ability to teach complex topics to diverse...
, quality, microbial/environmental, technical cleaning, validation, and mechanical, electrical and process automation issues...
need apply. This is NOT a validation engineering role. 8am-5pm, M-F 3 Key Consulting is hiring a Manufacturing Systems..., non-routine projects involving the planning, design, reconfiguration, construction, maintenance, validation and alteration...
(characterization, validation and trouble shooting) in the assembly of combination products. This position... and Validation of process and GMP equipment. They will own the site master validation plan for GMP equipment and will be responsible...
to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory..., prototyping, design verification. DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA. Nice to have: packaging process...