Pharmaceutical- Filling & Packaging Process Engineer

Previous Pharmaceutical/Biotech experience is mandatory for this role.

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR’s Engineering expertise includes Process, Automation, Facilities engineering. Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, Biotechnology (Vaccines, Blood Plasma Fractions, Monoclonal Antibodies).

This role is for Filling & Packaging Process Engineer to work on the filling and packaging operations within a sterile / aseptic pharmaceutical or medical devices manufacturing environment. Tasks may include all or in part, design / re-design, installation, start-up / commissioning, qualification as well as operation support for analysis, trouble shooting and / or process improvements of the filling / packaging equipment systems. The ideal candidate should possess technical as well as leadership skills to independently perform or manage resources and activities related to the filling and packaging operations.

The work is at our client site in Cincinnati, Ohio.

Responsibilities

• Lead or participate in design or operations of packaging pharmaceutical products into their final forms and containers by fill / finish and packaging like, vials, pre-filled syringes and other delivery systems like OSD or OLD process.
• Work with production and packaging groups to create User Requirements Specifications (URS) for ongoing operations or new projects
• Collaborate with vendors for packaging machinery, equipment systems, automation controls, materials and consumables, to create Design Specifications (DS) and Functional Specifications (FS) to implement solutions for reducing contamination risks & process failures
• Assess current packaging operations for troubleshooting, efficiencies and continuous improvement opportunities
• Spearhead innovations in packaging technologies to support existing client needs
• Perform reliability studies on packaging equipment
• Perform optimization studies for the optimal use of packaging equipment systems for use in campaigns
• Support documentation and/or execution of FAT / SAT / Commissioning, Qualification of packaging systems
• Coordinate meetings with cross-functional departments to drive project progress, facilitate decisions, provide updates to higher management
• Other duties as assigned by client, and / or MMR, based on workload and project requirements.
• Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases

Qualifications

• College / Bachelors’ Degree or Diploma in Engineering discipline, preferable Mechanical
• 4-6 years in GxP environment typically for design or operation of pharmaceutical packaging operations, including sterile / aseptic manufacturing
• Previous experience in the pharmaceutical / biotech industry, with knowledge of requirements for a cGMP operations
• Possess leadership skills and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity
• Ability to handle multiple projects and work in a fast-paced environment.
• Ability to lift 50 pounds
• Travel and / or off-hours work may be required on occasion

Send your resume to: recruitment@mmrengineering.com

Equal Employment Opportunity and Reasonable Accommodations

MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.