• Generate and execute equipment validations across each value stream as per the validation lifecycle and in accordance with the company requirements.
• Generate technical input to new equipment projects and document activities.
• Provide the technical support for new and current workflows across each value stream.
• Support the initial input for new capital projects.
• Support the execution of new capital projects.
• Provide input and support to the manufacturing area / Quality Assurance process analyses, troubleshooting, computer systems validations, validation protocols, metrics evaluation, process optimization, manufacturing planning among others.
• Responsible to ensure the investigations of discrepancies and must document comprehensive explanations regarding the discrepancy investigations as well as impact on product quality.
• Conducts validation and qualification activities that are in accordance with company policies & standards, as applicable. Activities include: Cleaning (cGMP), Lipe (ICCQP), environmental monitoring equipment, utilities & facilities.
• Performs other duties as assigned.

• Generate protocols and reports for process improvements and validations.
• Execute validations and associated modifications of equipment and facilities.
• Assist in the design reviews for new equipment and process improvements.
• Ensure all aspects of validation are met.
• Ensure the validation activities before finalization & prior to release are clear and aligned with Quality and Safety.
• Support validation efforts ensuring the resolution of the issues found.
• Ensure resolution of the regulatory issues that arise as part of the equipment investigation as well as industry changes.
• Support change controls, discrepancy reports, Factory Master Plan.
• Provide assistance to vendors as needed.
• Provide support to Quality, Facilities & Safety.
• Provide support to other areas as necessary.
• Support utilities and facilities assessments.
• Support planning of validation activities.
• Maintain the applicable policies, procedures, methods and practices including safety guidelines and GMP.
• Implements changes to change management process or qualification processes and SOPs.
• Follows safety procedures, recommended practices, etc. Job Safety Analysis (JSA), safe work permits, and comply with plant safety programs at all times.
• Maintain, understand, and practice safe working habits, safety rules and regulations.
• Maintain an open and effective channel of communication with Direct Supervisor, Technicians, and Functional areas. This includes sharing of information.
• Train Manufacturing/Packaging Team Leaders, Manufacturing Technicians, Reliability Technicians, Manufacturing/Packaging Operators, Instrumentation Technicians, Reliability Engineers, Automation Technicians/Engineers, Machine Shop and Facilities Mechanics.
• Provide guidance to the Technicians regarding investigation progress, implementation, operations impact, priorities control, work scope and / PM requirements, among others.
• Perform other duties as needed.

• Bachelor’s Degree preferably in Engineering or Natural Sciences (Microbiology, Biology, Chemistry, others).
• Prefer at least 5+ years of experience in equipment qualifications / Quality / cleaning validation or work experience.
• Previous experience executing utilities & facilities qualifications, computer systems qualifications, computer system validation (Process and Cleaning validation experience is preferable). 
• Has basic general technical knowledge, and specific discipline knowledge.
• Have good verbal and written skills. Can articulate issues and solutions to the team. Can produce effective project reports and presentations.
• Can effectively interact and collaborate with team members.
• Demonstrates respect for others.
• Encourages team participation.
• Capable of simultaneously managing multiple assignments.
• Organizes daily activities to assure timely completion. Flexible, firm, and responsive to changes.
• Computer literate.
• Fluent verbal and written skills in English. 

Physical & Mental Requirements:

• Must be able to work with stress.
• Standing or sedentary work requires frequently sitting, walking, standing, repetitive hand movement, simple grasping, and fine manipulation.
• Occasional move and lift (less than 10 pounds) and normal lifting.
• May be required to work various hours, shifts and schedules including weekends and holidays.
• Must understand and follow a set of complex and/or written procedures without deviation.
• Must adhere to a provided work schedule, when deviated group to obtain consensus.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 37.50/hr.