• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Responsibilities:

• Planning and execution of plant projects involving complex equipment changes.
• Work with Quality group to draft change requests and gain stakeholder alignment.
• Own change requests and complete change request tasks to support project completion.
• Daily on-site management for multiple projects – monitor contractors for (each project) daily, monitoring for PPE and safety compliance, assisting with issuing safety permits and handling day to day construction questions.
• Escalating concerns and discussing with manager or other stakeholders as required.
• Working with stakeholders to schedule construction related activities and communicate outages to affected parties.
• Redline drawings for as built and work with CAD group to get drawings updated, request new drawings etc. Work with CAD group to assemble TOP package docs.
• Ensure construction work is proceeding on schedule and work is being performed in a high-quality manner according to the drawings and project specifications.
• Execute commissioning protocols (installation, operation, CIP/SIP, wet testing).
• Gather pricing and assist with scoping upcoming projects.
• Work with vendors to specify and gather budgetary pricing for new equipment as needed.

Requirements:

• BS in Engineering or related field.
• Minimum 5 years working in Pharmaceutical Engineering Projects.
• Excellent written and verbal communication skills.
• Extensive knowledge of Change Controls and GMP manufacturing practices.

All your information will be kept confidential according to EEO guidelines.