Engineer II, QA

Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.)

Job Description

Quality Engineer II is a quality assurance professional with substantial prior experience of working within a Quality, Process Engineering, or Manufacturing organization in a highly regulated industry. This individual specializes in evaluation of production processes and performance in manufacturing and participates in projects to engineer quality improvements of existing production processes as well as the development of new processes to improve quality and efficiency. Other job duties include but are not limited to understanding contamination/cross-contamination, observing aseptic practices, performing daily GEMBAs of manufacturing areas, continuously assessing fit and finish of the facility, and performing compliance inspections within manufacturing areas. This role supports Manufacturing and Process Engineering by providing Quality input as needed, and requesting the initiation of deviations as they are identified. All activities are in support of producing and releasing quality bulk drug substance for clinical and commercial clients.

What will you do? (Responsibilities)   

• 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 obtain buy-in and cooperation 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 and diplomacy with internal and external customers is essential.

Education and Experience

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

Knowledge

• Understanding ‘why’ and not just the ‘how’ of processes and practices
• Knowledge of Quality practices and cGMP regulations and other international health authority guidelines
• Experience with investigational writing software system (Track Wise) along with root cause analysis tools utilized in deviation investigations
• Technical writing skills and the ability to write/revise procedures in document management software
• Tech transfer experience is a plus
• Experience with Lean Manufacturing and Six Sigma methodologies is a plus
• Excellent problem-solving and analytical skills

Skills

• Analytical, critical thinking, and problem solving skills
• Strong interpersonal skills
• Strong written and oral communication skills
• Strong math skills

• Strong attention to detail
• Strong Microsoft Office skills (especially Word and Excel)
  • Solid time management and organization skills

Abilities

• Understand and carry out instructions
• Effectively multi-task
• Work effectively in a dynamic environment
• Able to work under pressure
• Able to work independently
• Demonstrated ability to lead others
• Able to coordinate workload for junior team members
• Able to understand departmental as well as site priorities
• Ability to collaborate with colleagues at all levels of organization

Physical Requirements / Work Environment

• Lifting < 50 lbs. Walking, sitting, focus on computer screen for long periods.
• Able to gown, wear PPE, and work successfully in a clean room environment
   

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.