Engineer II, QA

Work Schedule First Shift (Days)Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description About Thermo Fisher Scientific: Thermo Fisher Scientific Inc. is a global leader in serving science, enabling our customers to make the world healthier, cleaner, and safer. With our mission to enable our customers to make the world a better place, we are dedicated to delivering exceptional products and services to support scientific research and discovery.Location/Division Specific InformationSt. Louis MO / Pharma Services GroupThe St. Louis site is a fast-paced biologic drug substance manufacturing facility. It operates around the clock and has employs around 1K people. The facility is focused on cell process development to support clinical and commercial manufacturing. The products produced here treat chronic health conditions, including cancers and other life-threatening diseases.This is a non-supervisory role, working with the Supervisor of QA Operations at the Thermo Fisher St. Louis site. This position will be expected to work a shift schedule that includes weekend work and on-call rotation. This is a 1st Shift, Wed-Sat schedule, 6AM-4:30PM.Discover Impactful Work: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 supervise activities from a quality perspective and provide QA-related input

Collaborate with multi-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 alignment 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 should be able to obtain agreement 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 used 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

BenefitsWe 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.Apply today! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Accessibility/Disability AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.