Principal Process Engineer

• 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.

Job Description:

• We are seeking a Principal Process Engineer with a strong background in GMP manufacturing and engineering.
• The ideal candidate will have hands-on experience in biologics, process systems, automation, and utilities with a focus on upstream and/or downstream processes.
• The role will be initially remote and then onsite in Wilson , NC, once the facility opens.

Responsibilities:

• Provide technical leadership in GMP large molecule biologics manufacturing.
• Engineer and modify processes to ensure efficient process start-up and reliable operations.
• Support greenfield and/or brownfield facility start-up including process systems, automation, and utilities.
• Collaborate with cross-functional teams on various projects and drive business solutions.
• Lead or support multiple complex engineering projects simultaneously.
• Synthesize business, technical, and financial information into actionable project plans.
• Ensure compliance with GMP and safety standards in all project phases.

Requirements:

• Bachelor's degree in engineering or a related technical field.
• Minimum 8 years of process/plant engineering experience in GMP biologics manufacturing.
• Experience with upstream and/or downstream manufacturing processes.
• Experience with Delta automation systems.
• Strong background in engineering, manufacturing operations, and project execution.
• Strong collaboration and project leadership skills.
• Master's Degree (MS), MBA, or Ph.D.
• PE (Professional Engineer) certification.
• FPX certification, Six Sigma, or Lean experience.
• Active participation in ISPE and/or ASME BPE.
• GMP Manufacturing experience.
• Engineering background.
• Team collaboration and project leadership.

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