Senior Project Quality Engineer - III

CQV (Commissioning, Qualification, and Validation) Specialist

Education Minimum Requirement:

Bachelor's and/or Master's Degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline. Will consider Associate degree if they have 7+years of relevant experience.

Required Experience and Skills:

• With Bachelor's Degree, at least 5 years of experience in a quality and compliance role the pharmaceutical industry or highly regulated industry.
• With Master's degree, at least 3 years of experience in a quality and compliance role the pharmaceutical industry or highly regulated industry.
• Over 3 years of experience with development, review and approval of User Requirement (URS), FAT, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for pharmaceutical and biotechnology manufacturing equipment, facilities and utilities.
• Strong contemporary knowledge of relevant current good manufacturing practices (cGMPs), regulations and current industry trends.
• Effective decision making, problem solving and communication skills. Ability to manage multiple priorities.
• Demonstrated ability to work in fast-paced, complex environments and escalate appropriately.

Preferred Experience and Skills:

• GMP quality experience with biological drug substance or drug product in an aseptic environment.
• GMP experience with qualification of equipment.
• Experience with Quality Risk Management.
• Project Management experience in a highly regulated industry.
• Experience with Kneat (Validation Execution System), SAP, Trackwise and/or GLIMS

*Note*: This is onsite role at Durham, NC for 1 year with possibility of extension.

Responsibilities:

Senior Specialist Contractor

Our Quality Assurance group ensures all materials inside our products and the products themselves are manufactured, tested, and distributed in alignment with our high standards of quality. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers, we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

Client will construct a new manufacturing facility to significantly expand its production capacity for TICE BCG (BCG Live for Intravesical Use), a medicine for the treatment of certain forms of bladder cancer. Global demand has outpaced our current maximum manufacturing capabilities. Once this new facility is fully operational, we will triple our current manufacturing capacity, which is expected to support the anticipated demand for TICE BCG for the foreseeable future. This investment reaffirms Client's longstanding commitment to producing this medicine for the patients who need it. The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.

The Quality Assurance Senior Specialist will support this expansion. Project activities requiring support include the capital project to construct the facility, process and technology introduction, compliance improvements, and manufacturing readiness to initiate production of commercial product. The focus for the position includes all aspects of Quality oversight for drug product, drug substance, media preparation, and sterile supply.

Position Responsibilities:

• Immediate project support on review and approval of commissioning and qualification (C&Q) documents to support project delivery.
• Provide QA support including critical / constructive review and approval of GMP documentation such as Quality Agreements, Quality Risk Assessments, URS, FAT, IQ, OQ and other technical documents to meet schedule milestones.
• Independently manage project assignments.
• Ensure all aspects of the project proceed in compliance with cGMP, regulations, and our Company's Quality Management System.
• Focusing on areas such as Commissioning, Qualification and Compliance covering Manufacturing Equipment (isolator, restricted access barrier, incubator, washer, autoclave, formulation vessel, lyophilizer, etc.).
• Review and approval of master batch records, executed records, technical protocols, investigations, change controls, SOPs, validation protocols, technical reports.
• Partner with site and above site functions to solve problems and achieve goals.
• Makes decisions guided by policies and procedures that impact the team's ability to meet performance objectives.
• Consults on an as-needed basis with next level manager on more complex decisions.