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 Validation Engineer is responsible for overall validation project ownership of high to low-risk projects (s) under limited to no supervision. Responsible for the generation and execution of validation protocols, assistance in audits, determination of validation needs, and training of Analysts. This job has no supervisory responsibilities.

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.

• Performs validation activities to assure compliance with government and customer requirements.

• 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.

• Assist in the Change Control process and prepare changes in control and validation history report for audits.

• Attend conference calls and meetings

• Effectively communicates project goals and progress to the Supervisor / Manager. Investigate validation deviations, document formal reports, and ensure the resolution of corrective action to complete the project.

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

• Review and 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 Coordinate validation efforts with mechanics, operators, and engineering Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements.

• Will be required to complete and pass GDP and GMP training courses.

• This position may require overtime and/or weekend work.

• Attendance to work is an essential function of this position.

• Performs other duties assigned. High-Risk Projects are generally defined as projects/customer accounts that have the following.

• Business needs of customers/projects may require considerable time commitments.

• High level of uncertainty in managing customer expectations.

• Have a validation approach with significantly more or more complex requirements in addition to the Validation Master Plan.

• This position may require extra hours and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.
• Performs other duties as assigned by the Manager/Supervisor.
• May or may not have established criteria, which may be subject to interpretation

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 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 a strong preference for medical devices or combination products.
• Experience with validating processes and protocols
• 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.
• Experience with executing validation protocols (IOQ, OQ/PQ)
• Possesses excellent organizational, time management, and multi-tasking skills to meet commitments and deadlines.
• Prior experience in protocol/technical writing and utilizing root cause analysis tools is required.
• Critical thinking skills, along with a strong collaborative approach, are required.
• Technical knowledge and experience around Process Validation practices, Medical Devices, and Sterilization processes is preferred.

For candidates in Illinois: This position's base salary hiring rangeis $97,280-$110,000, plus a 5% MBP annual performance bonus eligibility. 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), flexible spending account, and 401(k.

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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.