- Primary functional responsibility is the independent execution of processing suite maintenance activities within the policies and procedures of the client, while maintaining the highest level of proficiency in the responsibilities required of cGMP processing areas.
- Develop expertise in all primary job functions, enabling the ability to train others and update SOPs as required.
- Foster a customer service attitude within and among facility, equipment, and process operations personnel.
- Ensure work is documented in compliance with the ALCOA principles of data integrity, cGMPs, GLPs, and departmental procedures
- Complete assigned suite maintenance activities within the timeframes required by departmental and site procedures
- As required collaborate with team members to ensure completion of all Infrastructure Engineer tasks. This may include but is not limited to the following: processing material transfer requests and facility coordination actions.
- Author/Revise GMP Documentation (e.g., Standard Operating Procedures (SOPs))
- As required, prepare and execute investigations and change control records across various quality production systems.
- Bachelor's degree in Engineering, Biology, Chemistry, Biochemistry, or a related scientific field, with 0 to 2 years of experience
- Individual must be able to gown to meet cGMP or safety requirements (e.g., aseptic gowning or live virus/BSL-2 gowning)
- Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment
- Demonstrated critical thinking skills, and problem solving
- Strong written and verbal communication skills
- Mechanical aptitude
- Working knowledge of cGMP requirements
- Demonstrated ability to manage multiple tasks and priorities
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Facility Engineer - Horsham, United States - PAREXEL
Description
We are looking to fill a Facility Engineer - Suite Coordinator position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients located in West Point, PA. This position offers full benefits, sick time, 401K, paid holidays, and paid time off.
Description
The Facility Engineer - Suite Coordinator supports facility readiness and compliance in support of pilot-scale campaigns for the GMP manufacture of bulk biologic (vaccines and therapeutic proteins) clinical supplies.
Responsibilities
Qualifications
Required Skills and Experience
Desired Skills and Experience
About Parexel
Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies.
For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement.
Come join us
