Engineer II, QA

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Job Description

Quality Engineer II is a quality assurance professional with substantial prior experience working within a Quality, Process Engineering, or Manufacturing organization in a highly regulated industry. This individual specializes in evaluating 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 understanding contamination and 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 when identified. All activities are in support of producing and releasing quality bulk drug substance for clinical and commercial clients.

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 ensuring 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 cGMPs, 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 ones 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 CAPAs as needed.
• Conduct/participate in investigation interviews/RAPIDs as required.
• Obtain buy?in and cooperation to resolve issues and maintain a quality culture throughout Operations with no direct authority over interacting personnel; use tact and diplomacy with internal and external customers.
  

Education and Experience

• Bachelors 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.
• 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 systems (TrackWise) 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 up to 50 lbs.
• Walking, sitting, and focusing on a computer screen for long periods.
• Able to gown, wear PPE, and work successfully in a clean?room environment.
  

Benefits

We offer competitive remuneration, an 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

Additional Information

The environmental conditions at the site include clean?room requirements, cold room/freezer temperatures, exposure to loud noises, and variable PPE usage. The work schedule primarily involves the second shift (afternoons).

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