Process Engineer II

VIVEX BIOLOGICS GROUP INC & SUBSIDIARIES•Miami, FL

23h•Onsite

About The Position

The Process Engineer II is responsible for ensuring the organization is compliant with all applicable regulations and standards in the areas of process validations. In addition, this position leads process change and improvement throughout the different areas of the company, including manufacturing. Process Engineers also participate in technology transfer to ensure the processes necessary for new products are effectively translated to the manufacturing floor. The Process Engineer II makes use of statistical analysis methods, critical thinking, process development, and scaling principles to achieve the objectives mentioned above.

Requirements

BS in Biomedical, Mechanical, Industrial Engineering or other applicable engineering discipline.
A minimum of 3 years of experience in Tissue Banking, Device, Biologics, or pharmaceutical industry in a relevant engineering role.
Strong analytical, planning, project management, critical thinking, troubleshooting, and problem-solving skills.
Ability to effectively communicate with multidisciplinary teams.
Excellent technical skills and writing.
Strong knowledge of 21CFR 1271 regulations and AATB guidelines.
Highly proficient in project planning software.
Strong work ethics.
Applicants must be legally authorized to work in the United States. Vivex will not provide sponsorship or employment for candidates who require the 24-month STEM Optional Practical Training (OPT) extension. Please note this is not an offer of immigration sponsorship

Nice To Haves

Advanced degree (Master’s) a plus.
Leadership experience preferred.
Strong knowledge of LEAN manufacturing principles preferred.
Microsoft Project preferred.
CTBS certified (or certified within two years of employment).

Responsibilities

Provide backup support to the Director Research and Development Operations, as needed.
Perform critical review of Process Engineer I project plans and related documents to ensure implementation is accurate and timely.
Independently lead and coordinate cross-functional projects and related resources to ensure completion in a timely manner. Communicate to management of performance against plan.
Perform data and technical presentation reviews as needed.
Understand and apply the applicable regulations and standards for equipment qualification and process validation to ensure compliance.
Use statistical and analytical methods to understand processes.
Use LEAN Manufacturing principles to analyze and make recommendations for process optimization and implementation.
Work with other department heads or designees on projects as delineated on project plans to ensure timely completion of projects.
Develop equipment and process validation protocols (IQ, OQ, PQ) and reports as needed.
Lead and perform equipment qualifications and process validations as needed.
Develop and monitor process and equipment metrics to use for optimization analysis.
Develop and implement solutions with minimal supervision.
Comply with FDA and AATB tissue banking standards.
Other duties as assigned.