Process Engineer Associate

4 weeks ago

Clayton, Ohio, United States BioSpace, Inc. Full time

About the Department

At BioSpace, Inc., we are committed to improving the quality of life for millions of people worldwide. Our company has a long history of innovation and leadership in the field of pharmaceutical manufacturing.

We operate three state-of-the-art facilities that are responsible for fulfilling different steps in our treatment supply chains.

Our newest facility in North Carolina houses the Fermentation, Recovery and Purification in the production of ingredients for our innovative oral products.

As a Process Engineer Associate, you'll join a global network of manufacturing professionals who are passionate about what they do.

What we offer you:

  • Leading pay and annual performance bonus for all positions
  • All employees enjoy generous paid time off including
  • 14 paid holidays
  • Health Insurance, Dental Insurance, Vision Insurance - effective day one
  • Guaranteed 8% 401K contribution plus individual company match option
  • Family Focused Benefits including 12 weeks paid parental & 6 weeks paid family medical leave
  • Free access to BioSpace, Inc.-marketed pharmaceutical products
  • Tuition Assistance
  • Life & Disability Insurance
  • Employee Referral Awards

The Position

Ensure successful ramp-up of the process tracks. Process expert role in developing the project.

Primary tasks:

  • Provide input, review & approve design & requirement documents
  • Provide input, review & approve technical specifications

Relationships

Department Manager/Senior Manager.

Essential Functions

  • Support development of design & requirement specifications documents
  • Ensure quality of equipment & processes
  • Support the creation of process tracks risk assessment documents, such as Requirement Risk Assessments (RRA's)
  • Participation in the creation of a project cGMP Statement
  • Creation & participation in QRM risk assessments, such as Closed-Process, Cross-Contamination, Contamination & Facility flows
  • Input & review to Process FMECA's for the Process tracks
  • Participation in design work shops with engineering suppliers
  • Input & review of Process Module Diagrams, & Process Flow Diagrams
  • Input & review of Process Scheduling & Capacity Calculations
  • Support package in maintaining schedule adherence
  • Ensure coordination & collaboration between project & other site stakeholders
  • Gathering & ensure knowledge transfer to project from DK sponsor site
  • Other duties or tasks, as assigned

Physical Requirements

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role.

Qualifications

Bachelor's degree in science or engineering (preferably Mechanical, Electrical, Chemical or Industrial), or an equivalent combination of education & related experience in a GMP environment for more than five (5) years required

Bachelor's degree in engineering/related field or anticipated Bachelor's degree in engineering/related field by 6/30/24 required, or within 12 months of application required.

Minimum of one (1) year of work-related engineering experience in Manufacturing, Design, Maintenance or Process Improvement preferred

Knowledgeable in the following systems:

  • Instrument & Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), Reliability Centered Maintenance (RCM) a plus

Organization/Planning:

Proven expertise in planning/organization/execution of maintenance activities, following up on results & revising the work plan for complex problems being resolved by cross functional teams a plus

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At BioSpace, Inc. we recognize that it is no longer good enough to aspire to be the best company in the world.

We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures.

We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in.

Together, we're life changing.

BioSpace, Inc. is an equal opportunity employer.

Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to BioSpace, Inc. and need special assistance or an accommodation to apply, please call us at .

This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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