Manufacturing Process Engineer
Role Overview
The Process Engineer is responsible for identifying and mitigating manufacturing issues (i.e., Aseptic Filling, Capping/Lyo operations, etc.) for existing business, through strong engineering and process improvement methods.
The Manufacturing Process Engineer will play a critical role in creating/maintaining/improving manufacturing processes and procedures.
They will also lead/assist in the commissioning, qualification, and validation of process equipment.
All activities are focused on technical and operational support for the production, maintenance, and support staff in the areas of process improvement, equipment modification and optimization, safety and quality improvement, and increasing throughput.
This is achieved through individual effort and facilitation of teams, cross functional partnerships, tracking and analysis metrics, strong understanding, and utilization of good engineering practices, project management, and the use of Lean Six Sigma techniques.
Additionally, the Process Engineer may be called upon to assess and provide recommendations for determining staffing, equipment needed, equipment purchase, equipment installation, component layout, and line layout.
Full Job Posting
Qualifications:
- Minimum of 3-6 years working in a Pharma cGMP environment; equivalent combination of education and experience will be considered.
- Exposure to parenteral processing equipment and operations, including formulation, filling, visual inspection, and packaging equipment preferred.
- Ability to manage teams to execute on-the-floor activities such as FAT, SAT, IQ/OQ, and Engineering batches. Experience in a data-driven approach to root cause analysis and prioritization of continuous improvement
- Intermediate/Strong Computer Skills: Ability to perform more complex computer tasks and knowledge of various computer programs to support the operation of the Aseptic Filling Isolator and its relevant equipment/parts
- Ability to explain complex technical issues to external customers/agencies.
- Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
- Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
- High Standard of Report Writing
- #LI-AK2
- Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
- Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
- At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
About PCI Pharma Services
Global contract development and manufacturing organization for biopharma.
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