PCI Pharma Services | Senior Quality Engineer | philadelphia, pa

3 weeks ago

philadelphia, United States PCI Pharma Services Full time

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.

  • PCI Pharma Services | Senior Quality Engineer | philadelphia, pa

    3 weeks ago

    philadelphia, United States PCI Pharma Services Full time

    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...

  • Senior Quality Assurance Specialist

    2 weeks ago

    Philadelphia, Pennsylvania, United States PCI Pharma Services Full time

    About PCI Pharma ServicesWe are a leading global contract development and manufacturing organization (CDMO) providing comprehensive solutions for the pharmaceutical and biotechnology industries. Our purpose is to enable life-changing therapies through accelerated development, reliable manufacturing, and flexible packaging.Job SummaryThe Senior Quality...

  • Senior Quality Engineer

    3 weeks ago

    Philadelphia, United States PCI Pharma Services Full time

    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...

  • Digital Platforms Project Manager

    2 weeks ago

    Philadelphia, Pennsylvania, United States PCI Pharma Services Full time

    Job SummaryWe are seeking a seasoned Digital Platforms Project Manager to oversee the project management and JIRA management of our software development life cycle for PCI's proprietary customer platform, pci | bridgeTM.About UsAt PCI Pharma Services, we prioritize operational excellence, quality, and delivering life-changing therapies to patients. We...

  • Continuous Improvement Operations Manager

    2 weeks ago

    Philadelphia, Pennsylvania, United States PCI Pharma Services Full time

    About PCI Pharma Services">We are a leading global contract development and manufacturing organization (CDMO) providing fully integrated services from clinical to commercial drug development and production. Our purpose is to empower the life-changing therapies of today and tomorrow by creating exceptional experiences for our customers, employees, and...

  • Digital Solutions Project Manager

    2 weeks ago

    Philadelphia, Pennsylvania, United States PCI Pharma Services Full time

    About PCI Pharma ServicesAt PCI Pharma Services, we are committed to delivering life-changing therapies to patients worldwide. Our company provides a unique opportunity for individuals to join a team of dedicated professionals who share our passion for innovation and customer satisfaction.Salary InformationWe offer a competitive salary range of $90,000 -...

  • Senior Services Coordinator

    2 weeks ago

    Philadelphia, Pennsylvania, United States Philadelphia Senior Centers II Full time

    Job SummaryWe are seeking a skilled Senior Services Coordinator to enhance the quality of life of senior housing residents in Philadelphia, PA. The ideal candidate will have a bachelor's degree in social work or a related field and one year of experience in the aging or human service system.

  • Philadelphia Gas Works | Senior Attorney

    2 weeks ago

    philadelphia, United States Philadelphia Gas Works Full time

    Philadelphia Gas Works Looking for a challenge and ready to light up your career? Free Health Insurance Options– Free Dental Insurance – Flex Spending - Commuter Benefits - Pension Plan – Free Parking – Wellness Programs – Onsite Gyms – Tuition Assistance- PSLF Eligible Employer- Parental Leave The Philadelphia Gas Works (PGW) is the largest...

  • Speech Language Pathologist

    2 weeks ago

    Philadelphia, Pennsylvania, United States Quality Rehab Management-Philadelphia-PA Full time

    Quality Rehab Management is seeking a skilled Speech Language Pathologist for a 13-week travel assignment in Philadelphia, Pennsylvania. This opportunity offers a competitive weekly pay rate of $2346.0 and the chance to work with a reputable healthcare provider.About the AssignmentThis rehab-focused speech language pathologist role requires a professional...

  • Senior Associate, Mechanical Engineering

    2 weeks ago

    Philadelphia, United States L3 Technologies Full time

    Job Title: Senior Associate, Mechanical Engineer (New Grad - Philadelphia, PA) Job Code: 18719 Job Location: Philadelphia, PA Job Description: Under general supervision, the Sr. Associate, Mechanical Engineer is responsible for assisting lead mechanical engineers in design/analysis to support mechanical layout of power equipment and other Navy based...

  • Corrosion Technician

    5 months ago

    Philadelphia, United States MasTec Professional Services Full time

    Company SummaryMasTec Professional Services provides results-driven engineering, design, and integrated services to the power, oil & gas pipeline, and gas distribution industries. With a genesis in construction and a skilled team of multidiscipline engineers and project management professionals, we deliver end-to-end solutions for infrastructure projects...

  • Senior Associate, Mechanical Engineering

    2 weeks ago

    Philadelphia, United States L3Harris Full time

    Job Title: Senior Associate, Mechanical Engineer (New Grad - Philadelphia, PA) Job Code: 18719 Job Location: Philadelphia, PA Job Description: Under general supervision, the Sr. Associate, Mechanical Engineer is responsible for assisting lead mechanical engineers in design/analysis to support mechanical layout of power equipment and other Navy based...

  • Planet Pharma | Senior Quality Assurance Specialist | philadelphia, pa

    2 weeks ago

    Philadelphia, United States Planet Pharma Full time

    Overview The Senior Quality Assurance Specialist, Operations Investigations role will support review of deviations, investigations, protocols to support release of materials and products. The Sr. Quality Operations Investigations Specialist will also ensure compliance to procedures by supporting laboratory investigations and manufacturing deviation reviews....

  • Associate Quality Account Manager 1

    2 weeks ago

    Philadelphia, United States PCI Services Full time

    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. Job Title: Associate Quality Account Manager...

  • Continuous Improvement Engineer I

    2 weeks ago

    Philadelphia, United States PCI Pharma Services Full time

    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. Job Summary We are looking for a dedicated...

  • Planet Pharma | Supervisor, Quality Assurance, Raw Material Release | philadelphia, pa

    3 weeks ago

    philadelphia, United States Planet Pharma Full time

    616129 Supervisor, Quality Assurance, Raw Material ReleaseDirect HirePhiladelphia, PAThe position will help to represent the Quality organization in the oversight and monitoring of GMP release activities, including finished drug product. The position will be a key point of contact for communications between manufacturing and Quality, with the goal of...

  • Planet Pharma | Supervisor, Quality Assurance, Raw Material Release | philadelphia, pa

    3 weeks ago

    philadelphia, United States Planet Pharma Full time

    616129 Supervisor, Quality Assurance, Raw Material ReleaseDirect HirePhiladelphia, PAThe position will help to represent the Quality organization in the oversight and monitoring of GMP release activities, including finished drug product. The position will be a key point of contact for communications between manufacturing and Quality, with the goal of...

  • Senior Cloud Infrastructure Engineer

    2 weeks ago

    Philadelphia, Pennsylvania, United States SysMind Tech Full time

    Job Overview:SysMind Tech is seeking a highly skilled Senior Cloud Infrastructure Engineer to join our team in Philadelphia, PA. As a key member of our engineering team, you will be responsible for designing and implementing CI/CD pipelines to support various application development, testing, and deployment.Responsibilities:Design and implement scalable and...

  • Psychiatrist - Inpatient Services Opportunity in Philadelphia, PA

    2 weeks ago

    Philadelphia, Pennsylvania, United States Universal Health Services Full time

    Opportunity OverviewWe are seeking a board-certified/board-eligible psychiatrist for our inpatient services team at Friends Hospital in Philadelphia, PA.About the RoleThis is an excellent opportunity for both new graduates and experienced psychiatrists to join our multidisciplinary team on an adult inpatient unit. Located in Southeastern Pennsylvania, the...

  • Mechanical Manager

    7 months ago

    Philadelphia, United States PCI Pharma Services Full time

    JOB SUMMARY : Growing business looking for change leaders to lead the Mechanical organization to drive Operational Excellence, and long-term strategy to meet the demands of a broad customer base. This position is responsible for all aspects of Mechanical Maintenance, Electrical Technicians, Mechanics (Level 1-3). This includes system improvements,...