Sr. Project Manager/Engineer/ Manufacturing Engineer(Pharmaceuticals/M
1 week ago
Job Title: Sr. Project Manager/Engineer/ Manufacturing Engineer(Pharmaceuticals/Medical)
Location: Thousand Oaks, CA 91320
Pay: $77.00 per hour
Duration: 12 Months Contract
Job Description:
Please note we are looking for an engineer / technical/ maintenance/ utility background over bench work/ quality / lab
• Demonstrated problem solving and applied engineering skills in Pharmaceutical Industry.
. We're not looking for a regular PM/ Bus development/ R&D/ Technical. We're looking for a Project (not program) Manager who will oversee a manufacturing and engineering team. They need engineering knowledge and background and some knowledge of validation.
Preferred Qualifications / Skills / Experience
• Bachelor's degree in engineering or another science-related field
• 2+ years of relevant work experience with 1+ years’ experience in operations/manufacturing environment
• Direct experience with regulated environments (FDA, OSHA, EPA, etc.)
• Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments and equipment
• Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution
• Experience with combination product / medical device quality systems verification
• Process equipment knowledge – cell culture, fermentation, purification, filling, and packaging
• Process automation knowledge – understanding of automation infrastructure, current technologies, and automation project execution / verification.
• Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus
• Demonstrated strong communication and technical writing skills
• Strengths in facilitation and collaboration / networking
• Experience in developing SOPs and delivering training
• Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
• Good record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)
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