Quality Engineer - (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.

Summary of Objective:

The Quality Engineer - New Product Introduction (NPI) is a key, customer-facing role that will be responsible for the onboarding and support of new customer programs for the Philadelphia Site. The QE will beresponsible for the transition of new products and processes from engineering to manufacturing and the supply chain. This position will work closely with product engineering to define manufacturing requirements within the New Product Development process including all phases in Design for Assembly (DFA) through to Design for Manufacturing (DFM).

The QE will interact and collaborate with internal team members, customers, suppliers, and contract service providers. The position will be responsible for driving timeline commitments for new projects. The Quality Engineer will also function as a technical resource in deviations, defect analysis, complaints, establishing sampling plans, assessments, and protocols.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

Technical (Product and Process)

• Drive and support new customer programs throughout the development lifecycle and deliver on the 'One PCI' customer experience and program management
  • Interact with clients on an as-needed basis to support project milestones, scope changes and business development opportunities.
  • Develop and implement product and process workflows to ensure best engineering practices within the quality and engineering teams for DFA/DFM (DFMA) into sustainable engineering and commercial operations.
  • Test method transfer or method validation activities.

• Development of sampling plans for OQ/PQ activities (includes Serialization and Sterilization activities).

• Trend manufacturing data and contract service providers results.

• Development of validation/re-qualification protocols.

• Development of Master Batch Records, work instructions and associated manufacturing and packaging documentation.

• Drive root cause analysis of deviations/complaints.
• Support project teams through the selection of correct design / manufacturing concepts and fundamental technology to ensure successful project outcomes.
  • Develop work standards and packages as part of project acquisition process and following subsequent project delivery stages, to successfully deliver projects within scope, with quality, and within allocated timeframes and budget.
  • Identify opportunities and develop recommendations to improve product and process design.
  • Interpret product requirements and design and develop concepts, components, assemblies, and products in compliance with applicable quality system procedures, industry, and business standards.

• Supports the generation of documentation such as Measurement System Analysis (MSA), Control Plans, Process Flow Maps, Inspection plans and techniques, GR&R & test requirements.

• Maintain QE process discipline to achieve project deliverables, including but not limited to, supporting manufacturing strategy, capability analysis, FMEA, tooling selection, risk management, supporting cost modelling, DFM, and process validation/qualification.
  • Employ data driven tools and methodologies to implement structured and timely problem.

• Development and/or review of technical specifications

Supplier Quality

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

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

Leadership

• Collaborate with the engineering, business development and ancillary groups and wider development, manufacturing, and procurement teams.
• Attention to detail and self-motivation to deliver work to the highest standards.
• Multitasking, planning work, scheduling tasks, coordinating activities, and managing time efficiently.
• Timely problem-solving using data driven tools and methods.
• Presentation of quality standards, process flows, inspection plans, and/or issues both internally to stakeholders and externally to clients with confidence and accuracy.

Other - General

• Attendance to work is an essential function of this position
• Performs other duties as assigned by Manager/Supervisor within commercial operations (sustainment engineering).
• Support the recruitment, coaching, and development of quality engineers to achieve excellence and efficiency when programs are scaled.

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions

• Stationary Position: From 1/4 to 1/2 of the day.
• Move, Traverse: From 1/4 to 1/2 of the day.
• Operate, activate, use, prepare, inspect, or place: From 1/4 to 1/2 of the day.
• Install, place, adjust, apply, measure, use, or signal: Up to 1/4 of the day.
• Ascend/Descend or Work Atop: Up to 1/4 of the day.
• Position self (to) or Move (about or to): Up to 1/4 of the day.
• Communicate or exchange information: 3/4 of the day and up.
• Detect, distinguish, or determine: 3/4 of the day and up.
• On an average day, the individual can expect to move and/or transport up to 10 pounds less than 1/4 of the day.

This position may have the following special vision requirements.

• Close Vision Distance Vision Color Vision Peripheral Vision Depth Perception
• Ability to focus No Special Vision Requirements

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The following are some environmental conditions that one may be exposed to daily and for various lengths of time.

• Work is primarily performed at a desk and/or in an office environment. for 1/4 to 1/2 of the day.
• Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for up to 1/4 of the day.
• The noise level in the work environment is typically, moderate.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• College or Trade Degree required (engineering degree or related scientific degree). Must have a minimum of at least three 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 is 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.

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.