This mid-level position in our Covex Consulting Services team will support the testing, validation and implementation of large-scale regulated systems 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 include (but are not limited to):
- Gather, create and document requirements and data for new production systems.
- Draft documents required for the planning, technical, validation, operational, retirement phases of the System Development Lifecycle.
- Perform Gap-Analysis on current process equipment status.
- Assess new regulations and guidance documents in the use of systems in a GMP environment and develop/revise documentation to ensure continued compliance.
- 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.
- Bachelor’s of Science in Engineering required.
- 4 or more years of experience doing Validation, Commissioning or QA work within the Life Science, Pharmaceutical, Biotech, Medical Device Design or Construction industries.
- Proficiency using Microsoft Office tools.
- Must be able to read equipment and process schematics.
- 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).
Contact Senior Validation Consultant John Dearnaley at firstname.lastname@example.org for more information.