Job Title: Engineer Senior

Location: Thousand Oaks, CA

Duration: 12+ Months

Description:

looking for Engineer experience in a pharma manufacturing setting with process equipment experience please**

Preferred Qualifications / Skills / Experience

• Bachelor's degree in engineering or another science-related field

• 7+ years of relevant work experience with 5+ 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

• Understanding and awareness of industry/regulatory trends for verification/validation

• Experience with combination product / medical device quality systems verification

• Strong process equipment knowledge – cell culture, fermentation, purification, filling, and packaging

• Strong process automation knowledge – understanding of automation infrastructure, current technologies, and automation project execution / verification.

o 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

• Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)