This senior position in our Covex Consulting Services team will support the implementation, testing, and overall validation of regulated laboratory systems for Covex clients in a leadership capacity. Client systems are located in controlled industrial chemical and biological laboratories at some of the world’s largest and most advanced pharmaceutical companies. The senior engineer role will have responsibility over project management, Covex team oversight (for a specific project) and client interactions including status updates and metric reporting. This role will also actively validate systems themselves and deliver on project tasks.
Key Responsibilities include (but are not limited to):
- Support clients with their system implementation and configuration of laboratory systems.
- Define validation approach in alignment with client standards to include risk assessments, data integrity assessments and overall project planning.
- Implement the validation strategy for assigned systems to include:
- Gather, create and document requirements for new and existing (legacy) laboratory systems. Examples of such systems include LIMS, Empower, HPLC, GC, TOC, UV/Vis, Plate Readers and automated titrators.
- Draft documents required for the planning, validation, operational, and retirement phases of the System Development Lifecycle.
- Design and execute testing on the laboratory systems using various industrial testing tools.
- Participate in all phases of system testing, including:
- Draft, review, dry-run and execute test scripts on a variety of different applications using various testing tools.
- Collaborate with team to resolve system issues/errors.
- Take leadership role on projects reporting to a defined Covex account/project manager. Provide daily oversight, mentorship and guidance to Covex Validation Engineers assigned on same project.
- Engage with lab system vendors on behalf of client to review out of the box validation packages and define gaps that must be filled by the Covex validation deliverables for a given system on the project.
- Attend and lead project team and client update meetings, complete metric tracking forms, and track project tasks as required by the project.
- Act as first response on project issues and support creation of mitigation plans for issues and risks identified for the project.
- Submit weekly timesheets and status reports to Management.
- Bachelor’s degree in related science (Biology, Chemistry, or Biochemistry) required.
- Minimum 8 years of computer systems validation experience directly on laboratory computerized software and hardware systems.
- Solid understanding of GAMP5 methodology for Category 3, 4, and 5 systems.
- Experience performing Data Integrity Assessments to ALCOA++ standards.
- Proficiency using Microsoft Office tools.
- Excellent oral and written communication skills with ability to:
- Communicate effectively with the client and members of a diverse team.
- Document strategies, test findings and issues in clear, concise terms.
- Strong problem-solving and critical thinking skills.
- Outgoing personality with strong ability to be able to communicate effectively with members of a diverse team and document test findings and issues in clear, concise terms.
- Ability to work independently and as part of a team, with the ability to transition between the two.
- Excellent organizational and time management skills.
- Strong attention to detail.
- Ability and willingness to engage/communicate directly with the client and the project team in a leadership capacity including proven ability to manage and mitigate high pressure situations.
Additional Job Requirements:
- Position is full-time, forty (40) hours per week.
- Additional hours may be required on occasion.
- Ability to look at a computer screen for long periods of time.
- Capable of working in a variety of office setup configurations as designated by the client.
- Capable of working in a variety of laboratory/production/construction areas as designated by the client.
- Must be willing to occasionally climb ladders, or work on platforms and roofs that may exceed 30 ft.
- Job location is at the client site with intermittent travel to other client sites and the Covex Wayne, PA office. Therefore, must be able to travel by all modes of transportation.
- Willingness to travel as required – up to 100% (long distance driving and well as flight travel).