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Available Jobs

Senior Lab Information Systems / Data Integrity Validation Specialist

Duration: Full-Time

Location: Greater Philadelphia Area

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 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.


Key Competencies:

  • 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).

Director, Pharmaceutical Compliance Department, Midwest Region

Duration: Full-Time

Location: Indianapolis - Midwest U.S. Region

Position: Director – Compliance Department – Midwest Region

Description:  The Director role has a combination of internal and external responsibilities and reports directly to the Vice President of Compliance Services. The role requires a senior client facing person capable of managing projects and people independently out of the Midwest region of the United States. The selected candidate will also internally have direct management responsibility for up to six Managers/Sr. Managers. Specific responsibilities of this role include:

Internal Responsibilities

  • Identification of new and existing client business leads. Directly present Covex services to support business expansion.
  • Generate proposals for new or expanded client project work.
  • Assists the Director and/or Vice President in development of organizational strategies and department improvements.
  • Assists the Director and/or Vice President in alignment of projects and resources.
  • Organizes management teams and supports managers as required. Manage up to six managers of varying levels:
    • Ensure teams are properly trained and motivated
    • Manage employee issues as necessary
    • Ensure that teams are equipped with what they need to meet their objectives
    • Manage employee performance, communication and planning
  • Decision maker for employee promotion requests by Managers on their team.
  • New employee interviewing and direct hiring decisions (this includes both FTE’s and contractors).
  • Ensure teams are aware of and in compliance with company policies and procedures.

External Responsibilities

  • Continue to be fully billable on project work in a senior role.
  • Provide project management activities for projects.
  • Perform internal quality reviews of deliverables prior to submission to clients.
  • Mitigate project issues.
  • Provide technical expertise to members of their team as needed for projects.


  • Bachelor’s Degree or equivalent required.
  • Demonstrated capability to deliver on the Senior Manager Responsibilities previously defined.
  • In depth pharmaceutical work experience (10+ years) including direct experience with validation and overall system compliance covering at least one of the following areas: manufacturing, IT and/or laboratories.
  • Minimum 5 years of management or supervisory experience.
  • Strong project management and planning skills.
  • Strong oral and written communication skills.
  • Proven business development skills and capabilities (ability to generate sales)
  • Ability to look at a computer screen for long periods of time
  • Ability to travel by all modes of transportation, infrequent weekend travel maybe required
  • Sporadic 40+ hour work weeks