Qualifications:
B.S./M.S. degree in appropriate engineering/scientific field. Minimum of 8+ years post-Bachelors degree experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industry. Previous experience in process troubleshooting in a manufacturing environment, specific hands on experience with large molecule fermentation and/or protein purification required. Demonstrated problem solving and adaptability in fast pace enviornment. Ability to work independently and as a part of a cross-functional team. Excellent written and verbal communication skills.
Responsibilities:
Primary responsibilities for the process engineer include: -Independently or as part of team, plan, design and implement varied technical projects and studies requiring knowledge of engineering and/or the physical sciences -Collect and interpret information and develop solutions to projects of various scopes -Authoring protocols, technical reports, batch records, standard operating procedure and change control documentation -Resolving technical issues encountered during batch manufacturing and/or engineering study execution -Performing manufacturing investigations and authoring investigation reports Responsible for executing projects against key timing commitments, with appropriate documentation. Minimal supervision, guidance and direction is employed by the supervisor, however, periodic checks and reports are required to review soundness of technical judgment and the status/schedule of the effort. Off-shift and weekend work may be required.
B.S./M.S. degree in appropriate engineering/scientific field. Minimum of 8+ years post-Bachelors degree experience in a cGMP environment (e.g. Production, Development, Process Engineering, Technical Services or related field) in pharmaceutical/ biotech industry. Previous experience in process troubleshooting in a manufacturing environment, specific hands on experience with large molecule fermentation and/or protein purification required. Demonstrated problem solving and adaptability in fast pace enviornment. Ability to work independently and as a part of a cross-functional team. Excellent written and verbal communication skills.
Responsibilities:
Primary responsibilities for the process engineer include: -Independently or as part of team, plan, design and implement varied technical projects and studies requiring knowledge of engineering and/or the physical sciences -Collect and interpret information and develop solutions to projects of various scopes -Authoring protocols, technical reports, batch records, standard operating procedure and change control documentation -Resolving technical issues encountered during batch manufacturing and/or engineering study execution -Performing manufacturing investigations and authoring investigation reports Responsible for executing projects against key timing commitments, with appropriate documentation. Minimal supervision, guidance and direction is employed by the supervisor, however, periodic checks and reports are required to review soundness of technical judgment and the status/schedule of the effort. Off-shift and weekend work may be required.