Qualifications:
B.S. in engineering, chemical, electrical engineering, or computer science. The candidate is required to have 3 to 10 years pharmacetical validation experience. Must be familiar with manufacturing equipment an instrumentation and current industry validation standards. Must have excellent written communication, organizational, and project management skills.
Responsibilities:
The scope of activities for this position includes, but is not limited to: equipment validation/qualification activities (commissioning, IQ, OQ, PQ) associated with the following processes: • Sterilization (SIP, autoclaves, depyrogenation, decontamination) • Controlled Temperature Units (incubators, freezers, refrigerators) • Lyophilization • Developmental equipment, testing, or process studies • Process/Equipment Change Management • Equipment Annual Revalidations/Recertifications The successful candidate must be a self-starter, with strong analytical problem solving skills, independent project management experience, with well-established technical writing skills. The successful candidate should be able to examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand root cause, and implement preventive actions. Primary Activities: 1. Author technical documents such as protocols, feasibility studies, and deviation investigations that align with corporate standards and industry requirements. 2. Adhere to Change Control procedures and ensure processes are maintained in a validated state through recertification / re-validation activities. 3. Provide technical and/or investigational support in troubleshooting and resolving manufacturing process issues. 4. Partner (collaborate) with other internal departments (Operations, Quality, Plant Engineering, and Technology), and external centers of excellence (COEs) on process or validation related activities/events. 5. Conduct equipment/system reviews.
B.S. in engineering, chemical, electrical engineering, or computer science. The candidate is required to have 3 to 10 years pharmacetical validation experience. Must be familiar with manufacturing equipment an instrumentation and current industry validation standards. Must have excellent written communication, organizational, and project management skills.
Responsibilities:
The scope of activities for this position includes, but is not limited to: equipment validation/qualification activities (commissioning, IQ, OQ, PQ) associated with the following processes: • Sterilization (SIP, autoclaves, depyrogenation, decontamination) • Controlled Temperature Units (incubators, freezers, refrigerators) • Lyophilization • Developmental equipment, testing, or process studies • Process/Equipment Change Management • Equipment Annual Revalidations/Recertifications The successful candidate must be a self-starter, with strong analytical problem solving skills, independent project management experience, with well-established technical writing skills. The successful candidate should be able to examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand root cause, and implement preventive actions. Primary Activities: 1. Author technical documents such as protocols, feasibility studies, and deviation investigations that align with corporate standards and industry requirements. 2. Adhere to Change Control procedures and ensure processes are maintained in a validated state through recertification / re-validation activities. 3. Provide technical and/or investigational support in troubleshooting and resolving manufacturing process issues. 4. Partner (collaborate) with other internal departments (Operations, Quality, Plant Engineering, and Technology), and external centers of excellence (COEs) on process or validation related activities/events. 5. Conduct equipment/system reviews.