Quality Engineer -Sustaining Engineering (SE)

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 (QE) is a key, customer-facing role that will be responsible for planning, developing, implementing and monitoring the equipment and process validation strategy for PCI's Advanced Drug Delivery business.The QE will partner with other internal team members to ensure a successful design/tech transfer with NPI by directly supporting or driving validation processes with appropriate risk management leadership.

As the new product is fully scaled into commercial operations, the QE will be responsible or support all phases process qualification, ensuring the product is produced according to the established control plan, design and product specifications, and driving continual improvement by implementing validation strategies, conducting tests, and analyzing data to confirm compliance and functionality.

The QVE will interact and collaborate with internal team members, customers, suppliers, and contract service providers as needed.

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.

• Prepares and executes validation protocols (IOQ, OQ/PQ) and validation standards, validation statements, reports, summaries, and master validation plan for new customer/product/system project launch and maintains existing validated processes and coordinating internal and customer approvals, as needed.

• Ensures validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals as required.

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

• Trend manufacturing data and contract service providers results for ongoing process verification.

• Reviews and interprets standards, procedures, and specifications for dissemination relative to validation protocols.

• Review and/or approve User Requirement Specifications, Functional Specifications, and Engineering Study Protocols Review and possibly assist in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to qualify equipment.

• Harmonization/streamlining of validation activities

• Assistance with development of Master Batch Records, work instructions and associated manufacturing and packaging documentation.

• Drive root cause analysis of deviations.

• Support project teams through the selection of correct design / manufacturing concepts and fundamental technology to ensure successful project outcomes.

• Develop validation 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.
• Interpret product requirements and design and develop concepts, components, assemblies, and products in compliance with applicable quality system procedures, industry, and business standards.
• Effectively communicates project goals and progress to Supervisor / Manager. Investigates validation deviations, documenting in formal reports, and assuring resolution of corrective action to complete the project.
• Coordinate validation efforts with mechanics, operators, and engineering
• Attends conference calls and meetings

Leadership

• Collaborate with the engineering, commercial operations, procurement and ancillary groups and wider development, manufacturing, and procurement teams for high priority product-program initiatives.

• Attention to detail and self-motivation to deliver work to the highest standards.

• Multi-tasking, 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 device assembly and packaging operations. May assist in the areas of NPI as needed.

• Support the recruitment, management, coaching, and development of quality engineers to achieve excellence and efficiency when programs are scaled.

• Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements.

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 preferred). 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:

• Lean Six Sigma Certification, ASQ Certified Quality Engineer (CQE), or similar certifications are highly desirable.
• 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.
• Technical knowledge and experience around Test Method validation, Medical Devices, and Sterilization processes is preferred.

*The hiring rate for this position is $97.280.00-$115,520 plus eligibility for an 5% MBP. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.

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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.