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Available Jobs

Laboratory System Senior Validation Specialist

Duration: Full-Time

Location: Wayne, PA

LABORATORY SYSTEM-RELATED SENIOR VALIDATION SPECIALIST

Pharmaceutical Industry Experience Required

Position Summary:

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 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.

Key Competencies:

  • Bachelor’s degree in related science (Biology, Chemistry, or Biochemistry) required.
  • Minimum 10 years of experience in laboratory cGxP setting, with at least 5 years of computer validation experience directly on laboratory computerized software and hardware systems and at least 5 years of direct management of assigned team resources on a project.
  • 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).

Pharmaceutical Data/Testing Analyst (Entry Level)

Duration: Full-Time

Location: Wayne, PA

Position Summary:

This entry-level position in our growing Onshore Testing Services (OTS) team will support the testing, validation and implementation of large-scale regulated systems for Covex clients.  This is an exciting opportunity for a recent college graduate to establish themselves in a rapidly growing organization in a fast-paced environment.

Key Responsibilities: 

  • Participate in all phases of system testing, including:
    • Work closely with a diverse team to outline the testing approach and plan the testing effort
    • Draft, review, dry-run and execute test scripts on a variety of different applications using various testing tools
    • Collaborate with team members to resolve system issues/errors
    • Ensure system requirements and user processes are properly tested
  • Prepare system test plans and other project deliverables
  • Gather, create and configure data for new system data entry; perform data analysis/cleansing
  • Attend project update meetings, complete metrics tracking forms, and track project tasks as required by the project
  • Submit weekly timesheets and status reports to Manager

Key Competencies:

  • Bachelor’s degree required
  • Proficiency using Microsoft Office tools
  • Excellent oral and written communication skills with ability to:
    • Communicate effectively with members of a diverse team
    • Document test findings and issues in clear, concise terms
  • Strong problem-solving and critical thinking skills
  • 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.

Additional job requirements:

  • Position is full-time, forty (40) hours per week
    • Additional hours may be required on occasion
  • Job location is Wayne, PA with intermittent travel to client sites
  • Must be able to work with computer screen(s) for long periods of time