Method Engineer Jobs in Georgia (NOW HIRING)

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 authors 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.

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