Quality Engineer/Owners Rep

Job Description

Job Description

VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology, and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry.

We are hiring an experienced Quality Engineer/Owner's Rep to support the design, specification, and procurement process for process equipment in a new biotechnological facility. In this role, you will be responsible for ensuring the quality and reliability of our facilities, utilities, and process equipment through testing, validation, and quality assurance processes. This role will be a 12+ month contract in total. The first nine months of the project will be located in Philadelphia, with a possible transition to North Carolina.

Responsibilities

• Participate with the Design Team in the design, specification, and procurement of pharmaceutical manufacturing process equipment and systems.
• Collaborate with cross-functional teams including Engineering, Procurement, R&D, Quality, Validation, and Operations to implement Good Engineering Practices for the design, selection, procurement, of manufacturing process equipment for a new Biotech facility.
• Develop and review engineering documentation including P&IDs, process flow diagrams, equipment specifications, and vendor submittals to ensure that the manufacturing equipment meets all applicable requirements, including user, regulatory, safety, and business requirements.
• Manage safety, quality, cost, and schedule for assigned equipment.
• Manage the technical aspects of equipment selection, procurement, installation, and commissioning.
• Ensure all process designs meet cGMP, FDA, and other regulatory requirements.
• Align internal and external stakeholder requirements and communicate the owner’s intent, ensuring that stakeholders are aligned and identifying issues for resolution.
• Additional responsibilities as required.

Requirements

• Bachelor’s or Master’s degree in Chemical Engineering, Mechanical Engineering, or related field.
• 5+ years of experience in process and design engineering within the pharmaceutical manufacturing industry.
• Strong understanding of pharmaceutical processes and process equipment (e.g., Compounding/formulation, autoclaves, washers, stopper prep, syringe fillers, auto-inspection, packaging).
• Advanced knowledge of regulatory standards including cGMP, FDA, and ICH guidelines.
• Commitment to achieving results, ensuring that their discipline meets commitments and supports the project needs, on time, at budget.
• Excellent problem-solving, project management, and communication skills.
• Ability to work independently and in a team-oriented environment.
• Excellent attention to detail with commitment to quality and compliance.

VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries. VTI offers professional development, training, competitive compensation, excellent benefits, matching 401K, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence.

As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees.

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