Senior Quality Engineer - New Product Introduction (NPI)

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

The Senior Quality Engineer (Sr. QE) - New Product Introduction (NPI) is a pivotal customer-facing role at the Philadelphia Site. This position is responsible for onboarding and supporting new customer programs, transitioning products and processes from engineering to manufacturing and the supply chain. The Sr. QE collaborates closely with product engineering to define manufacturing requirements throughout the New Product Development process, encompassing all phases of Design for Assembly (DFA) and Design for Manufacturing (DFM). The Sr. QE provides leadership by mentoring and coaching junior Quality Engineers, establishing training programs, and ensuring adherence to quality standards. Acting as the primary contact for customer programs, the Sr. QE provides technical support during project milestones, manages scope changes, handles internal and external escalations and ensures compliance with global standards for strategic accounts.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Leadership

* Mentor and coach junior Quality Engineers in NPI and commercial areas.

* Establish and deliver training programs on QE principles, cGMPs, product, and process familiarity.

* Collaborate with engineering, business development, and cross-functional teams in development, manufacturing, and procurement.

* Ensure high standards of work, effective time management, and data-driven problem-solving.

* Present quality standards, process flows, and inspection plans confidently and accurately, both internally and externally.

Technical (Product and Process)

* Lead new customer programs through the development lifecycle, promoting best engineering practices.

* Develop and implement workflows and sampling plans for OQ/PQ activities.

* Analyze manufacturing data, conduct root cause analysis of deviations/complaints, and support design/manufacturing concept selection.

* Create and maintain work standards to ensure projects are delivered on time, within scope, and budget.

* Interpret product requirements and ensure compliance with quality system procedures and industry standards.

* Develop Master Batch Records, work instructions, and related manufacturing and packaging documentation.

* Support the generation of Measurement System Analysis, Control Plans, Process Flow Maps, Inspection plans, GR&R, and test requirements.

* Maintain process discipline to meet project deliverables, including manufacturing strategy, capability analysis, FMEA, tooling selection, risk management, cost modeling, Design for Manufacturing, and process validation.

* Review and develop technical specifications and use data-driven tools for problem-solving.

* Identify opportunities for product and process improvements and develop recommendations.

Supplier Quality

* Participate in External Audits of Suppliers/Contract Service Providers.

* Manage internal and external suppliers required to support product design tasks.

QUALIFICATIONS

Required:
* College Degree required (engineering degree or related scientific degree). Must have a minimum of at least
five years of experience in an FDA regulated industry with strong preference to medical device or
combination products.
* Demonstrated proficiency with personal computers, business software (e.g., MS Office) and technical
software (ERP and eQMS systems). Ability to create, use and interpret scientific tables, charts, and graphs.
* Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various
computer programs.
* Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels
pertinent to professional needs.
* Analytical ability to drive effective Root Cause Analysis (RCA) and critical thinking for complex problem
solving.

Preferred:
* Possesses excellent organizational, time management and multi-tasking skills to meet commitments and
deadlines.
* Prior experience in technical writing and utilizing root cause analysis tools is required.
* Critical thinking skills along with a strong collaborative approach are required.
* Lean Six Sigma or other formal process improvement skillsets are highly desirable.
* Technical knowledge and experience around Test Method Validation, Medical Devices, and Sterilization
processes is preferred.

Soft Skills
* Excellent communication skills, both written and verbal, with the ability to effectively present complex
information to diverse audiences.
* Strong leadership and mentoring abilities, with a track record of developing team members.
* Adaptability and resilience in a fast-paced, evolving environment.
* Exceptional problem-solving skills with a proactive approach to identifying and addressing issues.
* Demonstrated ability to build and maintain strong relationships with internal and external stakeholders.
* High emotional intelligence and empathy, for effective team collaboration and customer interactions.

#LI-LM

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, Diversity, Equity, and Inclusion (DEI) 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.