Process Engineer

Description

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart.  If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics.  We currently have an exciting opportunity available for a Process Engineer!

The general purpose of the Process Engineer is to provide process engineering /maintenance support to the Manufacturing Facility, support process design from an equipment and utilities perspective, develop maintenance tasks, establish engineering tools and programs to ensure that the facility is kept in a good state of repairs as well as all process equipment and that we are cGMP compliant from a facility, maintenance and engineering perspective. Direct and or assist capital engineering and process improvement projects. Serve as equipment /facility expert and interface with regulatory agencies on audits etc. Must have the ability to apply engineering theory, practices and principles to determine root cause of equipment failures and to perform equipment performance evaluations.

Qualifications

 Essential Functions (ES) and Responsibilities

• Key Duties (ES):

• Investigate and, where possible, devise /implement plans to eliminate any mechanical or maintenance problem which would affect production and work towards successful resolution.

• Develop efficient PM plans for all key pieces of manufacturing equipment etc. and provide troubleshooting expertise in all areas of plant operations and maintenance.

• Provide process engineering support for required equipment upgrades and or modifications and champion these efforts including writing and directing all change control activities/ deviations as required by our Quality Systems, OSHA etc.

• Coordinate all external and internal maintenance activities with the manufacturing managers ensuring that activities are performed in a cGMP compliant, efficient and timely manner.

• Support project development with load calculations of flow, cooling capacity, heating capacity, presures, etc.

• Directly support for new design, development, configuration and optimization of new projects and upgrades from inception through closeout.

• Provide process documentation and operating instructions for new projects and existing processes.

• Assist in and or champion investigation of deviations that are facilities/maintenance related etc. and ensure the appropriate corrective actions are taken.

• Asist n writing regulatory documents for FDA submission as required

• Continuously monitor the manufacturing operation to look for process optimization / debottlenecking opportunites and make techical engineering recommendations/changes as deemed necessary

• Serve as the technical liaison for all OSHA, regulatory and other audits that relate to the maintenance/facility aspects of the mAb manufacturing facility.

• Prepare annual evaluation and operational assessment reports of critical systems and equipment for review and final approval.

• Supervisory Duties: NONE
• Core Competencies/Behaviors:
  • Ability to coordinate and complete complex projects.
  • Excellent written and oral communication and presentation skills C
  • Computer literate in word processing and data entry

• Compliance Requirements (ES): The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

• Physical Requirements (ES):
  • Physical Demands:  Sit at desk using computer, Some heavy lifting required, climbing in order to inspect vessels, roof etc. constant movement.
  • Stressors:  Production  schedule changes and equipment breakdowns etc. frequent changes in priorities and managing multiple projects with aggressive timelines. 

• Travel Requirements: N/A
• Physical Location of Role: Boca Raton, FL

Minimum Job Requirements

• Education Requirements: Bachelor’s degree in Mechanical, Biochemical, or Chemical Engineering.

• Experience Requirements: Five to seven years of solid process engineering/maintenance experience in a cGMP, Pharmaceutical/Biological manufacturing environment.

• Essential Knowledge: Extensive experience with MS Project, Auto Cad and maintenance planning/scheduling related software 2000; excellent problem-solving skills, detail oriented, and excellent mechanical aptitude, mathematical and advanced statistical analysis skills.

• Certification(s): N/A
• License(s): N/A

Preferred Job Requirements

• Preferred Education Requirements: N/A                              

• Preferred Experience: N/A

In addition to competitive compensation, we offer a comprehensive benefits package including:

• 401K plan with employer match and immediate vesting

• Medical, Vision, Life and Dental Insurance

• Pet Insurance 

• Company paid STD and LTD

• Company Paid Holidays

• 3 Weeks’ Paid Time Off (within the first year)

• Tuition Assistance (after the first year)

• Easily accessible to Tri-Rail

• Free shuttle to the Boca Tri-Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify. 

 
ADMA Biologics is an Equal Opportunity Employer.