PET PROCESS ENGINEER

Provide technical process engineering support for oral solid dose (OSD) formulation operations to ensure safe, compliant, and efficient manufacturing. Execute process monitoring, troubleshooting, and continuous improvement to enhance robustness, quality, and cost performance. Contribute to GMP readiness and audit resilience by maintaining strong documentation, deviation/CAPA effectiveness, and data integrity. Support day-to-day supply continuity across PET operation by resolving issues and optimizing the operation process controls, and implementing changes under site change control. Enable PET ways of working through stewardship of assigned processes/equipment, collaboration across functions, and disciplined execution of improvement projects.

Typical Accountabilities

• Strategic Operations and Capacity Planning:
  • Support capacity and campaign planning by providing process input, risk assessments, service/cost/risk trade-off analyses
• Technology Strategy and Roadmap:
  • Contribute to technology roadmaps (e.g., PAT deployment, alarm rationalization, digital batch records/EBR improvements, single-use systems where applicable) by evaluating options and supporting implementation..
• Continuous Improvement:
  • Execute CI initiatives linked to OEE, yield/loss reduction, changeover time, and consumables optimization.
  • Identify and deliver projects that reduce product cost, improve product quality, enhance yield, and reduce material usage.
  • Model PET ways of working, including disciplined problem-solving and data-driven decision making.
• Quality and Compliance Governance:
  • Provide technical support to Formulation areas, including investigation and correction of manufacturing technical/quality issues to protect supply continuity.
  • Author or contribute to technical assessments for deviations, CAPAs, and change controls; drive right-first-time outcomes and robust closure.
  • Ensure alignment with cGMPs, site SOPs, and inspection readiness expectations.
• Process Monitoring and Digital/Data Strategy:
  • Conduct troubleshooting and root-cause analysis for unexpected trends or results affecting product quality or financial performance due to material or process factors.
• Change Control and Documentation:
  • Author/update/review area procedures, master batch records, and EBR steps to ensure stewardship and compliance.
• Stakeholder and External Engagement:
  • Represent Process Engineering in internal governance meetings and support audits (FDA/EMEA, corporate) as back-room or front-room technical SME for assigned scope.
  • Engage with internal and external stakeholders, including suppliers, to resolve technical issues and implement improvements.

Education/Experience: 

Bachelor’s degree in Engineering (Chemical or Mechanical Engineering preferred) with a minimum of three (3) years related experience and/or training.  Thorough knowledge of the pharmaceutical/medical device industry with emphasis in manufacturing, packaging, utilities, and related equipment (including automation).  Project management experience and proficiency required.  Knowledge and understanding of project management, and change control principles.  Ability to understand and utilize financial analyses to make good decisions in a manufacturing environment. Basic knowledge in automation and equipment programs/control

Language:

Fully Bilingual (English and Spanish)

Ability to read, analyze, and interpret general business (Business acumen), professional industry trend, including SHE area /technical/GMP and government regulations. Ability to write business case project proposals, plans, budgets and related project documents. Ability to write technical (both high and low level) specifications, procedures, plan, and reports. Ability to effectively present technical information and respond to questions from groups of peers, managers, and customers/stakeholders.

Digital Literacy:

Working knowledge of MS Windows Operating Systems. Windows applications such as Word, Excel, Access, Power Point and Project, among others.  Working knowledge on SAP, GVLMS and automation and basic programming. 

Would you like to be part of an excellent team of professionals?

Apply Today!

IPR provides a comprehensive benefits package for its employees. It includes: Health, Pharmacy, Dental and Vision Insurances, STD and LTD Insurances, Retirement Plan with company match and Profit Sharing among others.

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

iPR Pharmaceuticals & AstraZeneca embraces diversity and equality of opportunity! We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We follow all applicable laws and regulations on nondiscrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.