Job Description

Job Summary:

The PharmBio business Process Engineer actively supports pharmaceutical containment manufacturing on a day-to-day basis. The Process Engineer will utilize their knowledge of ILC Dover quality systems to drive compliance to ILC Dover, ISO 9001, and customer standards. As part of these actions, they will identify continuous improvement opportunities and participate in team activities that drives these opportunities to closure. The Process Engineer may also participate in customer facing interactions such as audits, and customer complaint responses.

Successful candidates will have cGMP experience in pharmaceutical and/or medical device manufacturing environments, a data driven approach, and a willingness to work together as a team.

This is an on-site position.

Job Duties:

• Provide technical support that encompasses testing and monitoring of equipment, current system processes and conducting risk assessments.
• Ensure that all existing equipment and processes in the manufacturing areas are fully documented via SOP/SW.
• Drive continuous improvement but revising, implementing and or creating standard work for SOP’s and new processes.
• Actively support equipment troubleshooting requests for any operations within the manufacturing area and ensure that equipment is optimally running within the manufacture’s specifications.
• Develop new validation protocols based on risk assessments analysis and revalidation activities.
• Lead and coordinate projects that include but are not limited to product development.
• Develop, configure and optimize processes from inception to start up and validation or certification.
• Prepares and presents technical and program information to team members and management
• Design, take measurements, test and interpret data to improve production, systems and established processes
• Maintains a working knowledge of government and industry quality codes and standards including ISO 9001:2015.
• Effectively manage cost and identify time constraints
• Provide detailed process documentation and operational instruction for work being conducted in the manufacturing area.

*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.

Job Qualifications:

• Bachelor’s degree in Engineering or related Technical Discipline
• Minimum 5 years of relevant experience.
• Experience in CAPA, root cause analysis and 8D.
• Six Sigma Green Belt or Black Belt.
• Proficient with word processing software; statistical analysis software (SPC); graphics software, CAD or Auto-Cad, order processing software, and database software.
• Proficient in using Microsoft Office Suite.
• Proficient with measurement, calibration, and test equipment.
• Demonstrates strong analytical, problem-solving skills.
• Strong written and verbal communication skills.
• Detail oriented, good organizational traits.
• Knowledge of general safety and hygiene practices.
• Ability to work in a team-oriented environment.

Desired Qualifications:

• Master’s or advanced degree in Engineering and or related field.
• Experience in a clean room environment and aseptic manufacturing environment.
• Mechanically inclined with troubleshooting aptitude.
• Knowledge of manufacturing methods, process & quality standards (ISO 9001:2015, 13485:2016, 21cfr820, 21cfr211).

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently exposed to work near moving mechanical parts. The employee is occasionally exposed to fumes or airborne particles. The noise level in the work environment is usually moderate.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required

by this job include Close vision, Color vision, Distance vision and Depth perception. While performing the duties of this Job, the employee is regularly required to walk and talk or hear.

The employee is frequently required to stand; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to sit; stoop, kneel, crouch, or crawl and taste or smell.

As an Equal Opportunity Employer, ILC Dover is committed to a diverse workforce. We offer competitive benefits including medical, dental, life insurance, 401(k), PTO, and more.

Background Check & Drug Screening Required

E-Verify Used

EOE/AA Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran

Applicants with a disability that need assistance applying for a position may email [email protected]