"Alerted.org

Process Engineer

Who we are?

We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients’ lives to as many people as possible.

With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees.

Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 280 employees.

Your role

Reporting to the Lead Process Engineer,

JOB SUMMARY:

Serves as a technical resource supporting company objectives with respect to engineering design, process, and implementation of chemical process and controls. Projects include but are not limited to manufacturing systems, sterile and non-sterile filing systems, process piping, utility systems, new facility construction and upgrades, and other applications.

ESSENTIAL DUTIES / RESPONSIBILITIES:

Engage in technical discussions with potential suppliers

Organize and write approved specifications based on the needs and requirements (User Requirement Specification, Functional Specification)

Scope projects/work (Request for Proposal, Request for Service)

Ensure the solution designed respects the established specifications(s)

Ensure that technical choices which may deviate from established specifications, or the implicit expectations of internal/external customers are documented and validated in a formal manner

Execute Projects and Tasks to the approved completion deadlines and within the defined budget

Work in partnership with external companies

Propose and apply solutions to mitigate and compensate for possible work delays and budget issues

Proactively alert site management to and mitigate potential problems

Ensure the successful commissioning of the project

Manage the installation, commissioning, and validation of equipment

Coordinate the various suppliers and vendors and ensure their compliance to health and safety standards and site procedures

Possess adequate technical expertise allowing problem resolution

Respect the data in the specifications

Communicate with affected stakeholders to coordinate activities with respect to their area constraints

Assist with commissioning and validation activities required to bring equipment into service

Write approved technical reports after commissioning activities

Serves in an expert role to assist in writing of qualification protocols, execution of qualification tests, and review and approval of qualification reports

Participate in operator training

Work with internal customers to define training requirements and provide technical content

Organize and/or administer training in collaboration with suppliers

Study the technical needs associated with new site investments

Participate in different project groups

Collect and analyze needs from internal and external stakeholders

Define technical solutions and implementations

Respect the technical, regulatory, and quality requirements issued by Management and Quality Assurance

Consider a wide array of necessary parameters (water production, energy consumption, quality, etc.)

Respect process flows, workshop ergonomics, and safety constraints

Ensure the documentation of completed projects is updated

Collect technical drawings from vendors for review and ensure they reflect the realized design

Create technical drawings of the factory and update according to approved documentation practices

Your profile

REQUIRED EDUCATION:

Bachelor’s degree in Chemical Engineering or related discipline with equivalent experience

Master’s Degree considered a plus

QUALIFICATIONS/EXPERIENCE:

Minimum 3 years in either a manufacturing environment, or equipment and packaging technology

Experience in a regulated environment (FDA) a plus

Experience with solids and liquids manufacturing equipment a benefit

Experience with plastic extrusion and molding a benefit

Experience with clean room environments and sterile manufacturing preferred

SPECIFIC SKILLS:

This position requires the ability to think critically to develop creative engineering solutions for new processes. It also requires the ability to think in specific, detailed terms when problem solving for existing processes. Additional required skills are:

Demonstrated experience in reading and writing Piping and Instrumentation Diagrams (P&IDs)

Ability to specify, procure, oversee installation, commission, and oversee validation of systems and processing equipment

Strong background in technical troubleshooting and problem solving

Detailed knowledge of equipment operation and validation requirements

Ability to work in a matrix organization with cross-functional teams

Strong project management skills

Proficient knowledge of pharmaceutical cGMP requirements and systems

Proficiency in Microsoft Office suite, including non-routine applications like Access, Visio, and Project

Proficiency in Computer-Aided Drafting (CAD) software like AutoCAD

PHYSICAL REQUIREMENTS / ENVIRONMENT:

Traditional office environment with frequent visits to other areas of the facility including mechanical areas, production areas, loading docks, and laboratories

Must be able to work on a computer for extended periods of time

Must wear safety glasses and other protective items as required

Sitting 75% of the day; standing or walking 25%

Ability to travel for business (Domestic and International)

Compensation range

82,000.00 - 96,000.00 USD

*The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Learn more about us:

We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.

Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation. We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.

We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.

We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.

Join us and make a difference!