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Available Jobs

Laboratory System Related Validation Consultant (Mid-Level)

Duration: Full-Time

Location: Wayne, PA and other locales

Description:

Work consists of development and execution of System Life Cycle documentation for analytical systems and related software/database packages. Responsibilities include documentation development, lab system configuration, system testing, system troubleshooting, and Standard Operating Procedure (SOP) implementation. Examples of systems include (TOC, AA, UV-Vis, HPLC, GC, etc.)

External Responsibilities:

• Provide project-related task management activities for projects.
• Perform internal quality reviews of deliverables prior to submission to clients.
• Mitigate project issues.
• Provide technical expertise to members of the team as needed for projects.
• Identify new prospective clients and assist with the expansion of the core client base of Covex.
• Track existing project status; identify possible project issues and mitigate them.

Pre-requisites:

• Bachelor’s degree in related science (Biology, Chemistry, Biochemistry, Biomedical) or Chemical Engineering field required.
• 5+ years’ overall experience in a laboratory cGMP setting required.
• 3+ years’ experience in validation, qualification, or related compliance field.
• Strong understanding of System Development Life Cycle, 21 CFR Part 11 and Eudralex Annex 11
• Strong understanding of Data Integrity (ALCOA+ principles).
• Excellent writing skills; capable of adequately using Microsoft Office tools.
• Outgoing personality with strong oral and communication skills; demonstrated ability to work well with new peers.
• Ability to work in a team environment and be capable of delivering on critical client demands.
• Ability to travel by all modes of transportation; infrequent weekend travel maybe required.
• Sporadic 40+ hour work weeks.


Validation Consultant – Mid-Level (Automation Systems)

Duration: Full-Time

Location: Wayne, PA and other locales

Location: Covex Office – Wayne, PA

Client Site: US/International

 Position Summary:

This mid-level position in our Covex Consulting Services team will support the documentation development, system configuration, system testing, system troubleshooting, and Standard Operating Procedure implementation for analytical and control systems and related logic/software/database packages for Covex clients.  This is an exciting opportunity to get hands-on experience with a rapidly growing organization in a fast-paced environment.

Key Responsibilities (partial)

  • Gather, create and document requirements and data for new production systems.
  • Draft documents required for the planning, technical, validation, operational, and retirement phases of the System Development Lifecycle.
  • Perform testing on a variety of manufacturing equipment and utilities using various 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.
  • Attend project update meetings, complete metrics tracking forms, and track project tasks as required by the project.
  • Submit weekly timesheets and status reports to Management.

Key Competencies:

  • Bachelor’s degree in related engineering discipline (chemical, biotechnology, etc.) required.
  • Minimum of 3 years of experience working in pharmaceutical cGMP engineering setting required.
  • Experience with validation of shop floor manufacturing systems, PLCs, SCADA and Distributed Control Systems is preferred.
  • 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.

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 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).