Process Engineer

Industry

Engineering

Advert ID

FOX_BBBH196511

Location

Rocky Mount

Job Type

Contract

Hours

Full-Time

Salary Range

Up to USD0.00 per year

No. of Openings

1

Branch Information

Michigan Engineering - (USA) 2851 Charlevoix Drive Southeast Suite 323 MI Grand Rapids , MI 49546

ContactNumber

616-285-8967

Job Description

How You Will Achieve It



* Executes projects assigned by Process Engineering Manager or Engineering Lead.

* Coordinates all work on scheduled projects needed to meet the deadlines developed by Plant Capital Plan, New Product Introductions, and New Process Technology Developments.

* Responsible for manufacturing engineering support, the development of new process technologies, and the support of new product introductions/tech transfers.

* Organizes testing associated with the development of new process technologies and the support of new product introductions/tech transfers.

* Works closely with site tech. services to develop and confirm Critical and Key Process Parameters needed for Equipment and processes. Develops and delivers presentations to communicate project timelines and milestone completions.

* Contribute to Project Technical Teams, communicate and collaborate effectively to ensure effective interactions with all stakeholder groups.

* Design technical/engineering studies, writes technical reports summarizing study results and generates necessary data to support process development for new equipment, process changes, commodity changes and/or investigation/CAPA support.



Must-Have



* Bachelors degree is preferred with at least 1+ years of working experience (will consider candidates with a HS Diploma or Associates with at least 6+ years of experience)

* Proficient in Microsoft Word, Excel and PowerPoint.

* Knowledge of cGMP, safety and environmental regulatory requirements.

* Strong leadership, organizational planning and project management skills, in addition to technical knowledge, is required to work with multi-disciplinary teams.

* Good interpersonal effectiveness and communication skills (written and oral) are required in order to interface across cross functional teams, both technical and non-technical.

* Pharmaceutical or manufacturing experience and strong, demonstrated technical skills exhibited in a cGMP environment are requirements. Specific knowledge of and experience with Drug Product processing and equipment is highly desirable.

* An aptitude for understanding process technology and equipment, decision making ability, and excellent oral and written communication skills are essential. Candidate must possess flexibility to respond to changing conditions and priorities.

* Understanding of automation systems/applications a plus.



Nice-to-Have



* 2-5 years in pharmaceutical industry engineering preferred.

* Manufacturing experience with demonstrated technical skills related to pharmaceutical processes are highly desired. Preference of experience with sterilization processes: equipment, component and final product.

* Understanding of global regulations on data integrity and FDA 21 CFR Part 11 requirements

* Understanding of basic manufacturing processes and data recorded both electronically and on paper records.