BioSpace · 2 days ago

Qualification Engineer

Monmouth Junction, NJ

Full-time

Onsite

Mid Level

3+ years exp

Wonder how qualified you are to the job?

Maximize your interview chances

BiotechnologyCommunities

Comp. & Benefits

Insider Connection @BioSpace

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Responsible for Qualification Engineering activities, including writing protocols and reports complying with cGMPs, SOPs and FDA requirements

Responsible for supporting and assisting Engineering qualification function by providing documented evidence all company equipment is qualified and remains in a state of control to deliver processes and products complying to all regulatory and business specifications

Provides Engineering support and collaborates cross functionally with Operations, Packaging and Manufacturing departments on appropriate qualification, programming and troubleshooting issues

Responsible for design, writing and executing qualification protocols, tests and reports including, but not limited to: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for production equipment based on user, quality, technical and functional requirements

Responsible for organizing and maintaining the Engineering File Library.

Creates and revises SOPs, as needed

Maintains Laboratory, Manufacturing and Packaging equipment validation schedules, testing and developmental roll-outs

Prepares appropriate Change Controls and performs associated tasks in an accurate, timely, effective and compliant manner

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

manufacturing systemsSOPsCGMPsQualification protocolsDocument interpretationMicrosoft OfficeFluent in EnglishAnalytical thinkingProblem-solvingAdaptabilityCommunication skillsIndependenceCollaborationTime managementOrganization

Required

Bachelors degree in Engineering and minimum 3 years Qualification, Validation and/or related experience in the pharmaceutical or biotechnology industry

Working knowledge of good manufacturing systems and familiarity with regulatory and manufacturing SOPs and cGMPs

Hands on experience working with qualification protocols (i.e., IQ, OQ, PQ)

Demonstrated ability to read and interpret documents such as safety and environmental policies, operating and maintenance instructions and procedure manuals, etc.

Proficiency with Microsoft Office, including Project

Excellent verbal and written communication and skills

Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members

Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines

Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects

Fluent in English (verbal and written)