Project Engineer

Job Summary:

Perform basic process engineering design to select appropriate equipment technology for a given process. To prepare detailed capital project request reports for various Engineering projects.Execute Project Controls not limited to Forecast, Spending  to Engineering projects portfolio.Evaluate process control, monitoring, data acquisition and other support requirements for the manufacturing.

Job Responsibilities

• Manage projects involving installations and upgrades of equipment for adhesive blending,coating and packaging.

Perform basic process engineering design to select appropriate equipment technology for a given process. To prepare detailed capital project request reports for various Engineering projects. Evaluate process control, monitoring, data acquisition and other support requirements for the manufacturing.

Job Responsibilities

• Perform basic process engineering design to select appropriate equipment technology for a given process.
• Prepare detailed capital project request reports for various Engineering projects.
• Evaluate process control, monitoring, data acquisition and other support requirements for the manufacturing.
• Project implementation, ensuring throughout that the design criteria, safety standards, budgets, timelines, and all other project matters are met.
• Validation master plan development including equipment, facilities, computerized systems, cleanings and processes (IQ/OQ/PQ).
• IQ/OQ/PQ protocol development and summary reports for equipment, facilities, computerized systems, cleaning and processes.
• Preparation, revision and updating of schedule for validation activities.
• Development of Standard Operation Procedures (SOPs), Preventive Maintenance (PM’s), and calibration programs at equipment/instrument/facility/process start-up.
• Equipment, support systems and facility modification and repair assessments for impact study and to determine revalidation requirements.
• Assure that maintenance support and training, and operator training are sufficient to operate process equipment efficiently.
• Interface with operating production and R&D management to schedule current projects.
• Assist R&D personnel during scale-up with equipment planning and operating issues.
• Responsible for supporting GMP documentation required modifications to existing equipment and new equipment including creation or revising User Specification Requirements, Commissioning protocols,  Work Instructions, Training material and co-generation of Standard Operating Procedures, Safety procedures (Loto, ect).
• Provide support to Senior and P.E. II Engineers with large scale projects.
• Works as a member of a team to achieve all outcomes
• Performs all work in support of our Corporate Values of Pride, Accountability, Intergrity and Diligence; Demonstrates strong and visible support of our values
• Performs all work in accordance with all established regulatory and compliance and safety requirements
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion

• All other relevant duties as assigned.

Qualifications

• Education
  • B.S. Engineering degree

• Knowledge, Skills and Abilities

• Current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA), Pharmaceutical Manufacturing SOPs and other regulatory requirements.
• Business English usage, spelling, grammar and punctuation.
• Basic mathematical and statistical computation methods and practices.
• Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents.
• Ability to respond to common inquires or complaints from regulatory agencies, or members of the business community.
• Ability to effectively present information to management.
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. 
• Ability to apply mathematical operations to such tasks as frequency distribution, DOE, RCM (Reliability Centered Maintenance), analysis of variance, correlation techniques, sampling theory, and factor analysis.

• Experience
  • Ten (10) years related experience and/or training; or equivalent combination of education and experience. 

Salary : $80,000 - $120,000