Engineer II, QA

at  Thermo Fisher Scientific

EDUCATION AND EXPERIENCE

Bachelor’s Degree (BA/BS) in Life Sciences (biology, chemistry, biochemistry), Engineering, or a related field, with three (3) years of experience.
Experience with cell culture, protein purification, formulations, or facilities/utilities in a GMP pharmaceutical or biopharmaceutical environment is preferred.
Cleanroom manufacturing experience with full ISO 5 and ISO 7 gowning requirements is highly preferred.
Non-science degrees will be considered with a minimum of seven (7) years of directly related work experience in biopharmaceutical manufacturing.

KNOWLEDGE

Understanding of Quality practices, cGMP regulations, and international health authority guidelines.
Familiarity with investigational writing software (Track Wise) and root cause analysis tools.
Strong technical writing skills and ability to author/revise procedures in document management software.
Tech transfer experience is a plus.
Knowledge of Lean Manufacturing and Six Sigma methodologies is advantageous.
Excellent problem-solving and analytical skills.

SKILLS

Analytical, critical thinking, and problem-solving abilities.
Strong interpersonal, written, and oral communication skills.
Attention to detail and strong math skills.
Proficiency in Microsoft Office, especially Word and Excel.
Solid time management and organizational skills.

ABILITIES

Successfully complete tasks according to given instructions.
Multi-task efficiently in a dynamic environment.
Work effectively under pressure and independently.
Demonstrate leadership and coordinate workloads for junior team members.
Understand departmental and site priorities.
Collaborate with colleagues at all organizational levels.

PHYSICAL REQUIREMENTS / WORK ENVIRONMENT

Ability to lift < 50 lbs, walk, sit, and focus on a computer screen for extended periods.
Ability to gown, wear PPE, and work successfully in a clean room environment.

• Spend the majority of work hours in manufacturing areas supporting active processing and working closely with Manufacturing and Process Engineering to oversee activities from a quality perspective and provide QA-related input
• Collaborate with cross-functional teams to develop, optimize, and improve processes to enhance efficiency, productivity, and quality
• Conduct thorough audits and inspections to ensure sustained compliance with industry standards and regulations in preparation for internal quality audits, client audits, and regulatory inspections
• Observe aseptic practices and provide immediate coaching to site colleagues to prevent contamination and cross-contamination
• Participate in client and regulatory audits as a SME on the Fit and Finish, Changeover, and Change Control procedures and practices
• Observe critical process steps assuring adherence to guiding procedures, batch records, and established aseptic practices and be available to manufacturing and PE for support in real time
• GEMBA all active areas daily as well as other areas within the core as scheduled, and provide immediate feedback to colleagues and area management to ensure compliance with cGMP’s, site procedures, and regulatory requirements
• Perform QA approval of suite and equipment changeover between client processes
• Perform autoclave logbook review and facilitate corrections
• Perform Fit and Finish inspections per the risk assessment and guiding procedures
• Perform monthly aseptic observations of critical activities performed in Biosafety Cabinets
• Attend and actively participate in MFG huddles
• Lead/attend and actively participate in QA OTF Tier 1 huddles
• Act as Quality Management Representative for the company as needed
• Take actions to develop one’s own knowledge and skills
• Perform all training requirements in a timely manner
• Provide training, coaching, and mentorship to new and/or less experienced team members on quality standards and effective strategies
• Qualify new team members to perform tasks that require QSME training
• Write and review deviations in Trackwise as required
• Author, revise, and review procedures in eDMS as required
• Write and implement CAPA’s as needed
• Conduct/participate in investigation interviews/RAPIDs as required
• Individuals in this group must be able to acquire agreement and partnership to resolve issues and maintain quality culture and quality standards throughout Operations with no direct authority over the people with whom they interact. Utilization of tact with internal and external customers is crucial.