Quality Engineering Senior

Description
This Sr. Quality Engineer role provides technical leadership/ownership for analytical method development, validation, transfer, and stability activities supporting product lifecycle management, process improvements, investigations, and regulatory compliance.

Essential Duties And Responsibilities

Owns test method and equipment qualifications for lab`oratory systems

Supports equipment qualifications and process changes for N2O4 manufacturing

Owns the design, implementation, maintenance, and periodic review of the product stability program.

Develops stability protocols, sampling plans, pull schedules, and stability reports.

Evaluates stability trends and data to support shelf-life assignments, expiry dating, and regulatory submissions.

Performs annual stability program assessments and identifies adverse trends.

Supports investigations associated with stability failures, atypical results, and OOS/OOT events.

Updates and author procedures as needed

Designs and executes analytical method validation, verification, transfer, and lifecycle activities in accordance with ICH Q2, USP, FDA, and applicable regulatory requirements.

Establishes validation strategies including accuracy, precision, specificity, linearity, range, robustness, detection limit, and quantitation limit assessments.

Performs statistical analysis and interpretation of validation data.

Provides technical justification for acceptance criteria and validation approaches.

Supports method transfers between laboratories and external testing partners.

Maintains validated state of analytical methods throughout the method lifecycle.

Performs periodic review of validated methods and identifies opportunities for improvement or revalidation.

Evaluates method performance through trend analysis and laboratory investigations.

Applies risk management principles to validation and qualification activities.

Develops scientifically sound justifications and risk assessments supporting validation decisions.

Supports computer system validation activities including validation planning, risk assessments, testing, and change management in accordance with GAMP5 and 21 CFR Part 11.

Provides validation and stability support for combination product design changes, process changes, and regulatory submissions.

Assesses quality and regulatory impact of proposed changes to test methods, manufacturing processes, materials, and equipment.

Supports responses to regulatory inspections, audits, and agency inquiries related to validation and stability activities.

Ensures cGMP compliance to all company policies and procedures.

Performs routine data integrity audits of laboratory systems

Provides technical oversight and mentoring for validation and laboratory personnel.

Reviews and approves validation documentation generated by junior staff.

Serves as subject matter expert for analytical methods and stability program requirements.

Performs basic troubleshooting/equipment repairs on analytical equipment

Maintain knowledge of current regulatory requirements pertaining to drug/device manufacturing and communicates requirements to associate staff members.

Other duties as assigned.

Qualifications
Education

Bachelor's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biomedical Engineering, or related scientific discipline.

Experience

7-10 years in FDA-regulated pharmaceutical, combination product, medical device, or biotechnology industries.

Minimum 5 years of experience in analytical method validation and/or stability program management.

Demonstrated experience authoring validation protocols, reports, and technical justifications.

Preferred

Experience with ICH Q1A, ICH Q2, USP requirements, and shelf-life justification.

Experience supporting FDA and ISO 13485 regulated environments.

Experience with statistical analysis software (Minitab, JMP, Excel statistical tools).

Competencies

Analytical— Ability to perform calculations, assess results against set specifications

Design—N/A

Problem Solving—Inform a senior lab or manufacturing personnel or management of any problems encountered before during and after validation executions that could impact the integrity of the results.

Technical Skills—understanding of basic chemistry

Teamwork—Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.

Safety and Security—Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.

Opportunities—Asks for and offers help when needed.

Supervisory Responsibilities

N/A

Physical Demands and Work Environment

Continually required to talk or hear.

Must be able to read, write, and communicate fluently in English.

Frequently required to utilize hand and finger dexterity

Occasionally required to climb, balance, bend, stoop, kneel or crawl

Continually utilize visual acuity to operate equipment, read technical information inspect color differences, and/or use a keyboard

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