Position would require the candidate to be a W2 employee of Donatech.
US Citizenship / Permanent Resident Required.
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.)
- Demonstrated skills in the following areas :
- Problem solving and applied engineering.
- Basic technical report writing.
- Verbal communication
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