Posted in Other 30+ days ago.
This job brought to you by America's Job Exchange
Type: Full Time
Location: Exton, Pennsylvania
Under general supervision, the Process Associate II of Support Operations will be responsible for supporting and executing the commissioning, startup, and routine operation of the support operation equipment and production suites in a cGMP biopharmaceutical pilot plant. Once the facility is operational, the individual will provide manufacturing expertise in support operations and systems for the manufacture of preclinical, phase I, and phase II clinical materials, including assisting in the transfer of new technologies/processes, operation, and troubleshooting of support process equipment, preparation, and close-out of documentation, preparation of media/buffer solutions utilizing disposable mixing technology, raw material sampling and submission, and ensuring compliance to relevant regulations.
Under general supervision, the Process Associate II will also assist with the procurement and planning of raw materials and components, and assist in managing the supply chain logistics for material movements external and internal to the facility while ensuring compliance to relevant regulations.
1. Provide manufacturing expertise and work in a hands-on capacity in the startup and operation of Support Operations equipment for the manufacture of preclinical, phase I and phase II clinical trial materials. Responsible for supporting and executing the coordination of equipment maintenance, calibration, and validation with appropriate internal departments. Provide support for the transfer of new processes and technologies for media, buffer and excipient preparation working with R&D and the technology transfer laboratory personnel. Provide cross-functional support for other departments within the pilot plant at the discretion of management
2. Collaborate with Sr. Supply Chain Planner in creating SAP purchase orders for procurement of raw materials and components.
3. Support the supply chain logistics including oversight of material movements external and internal to the facility working closely with Warehouse staff. Works with outside suppliers to store and retrieve materials based upon manufacturing schedule. Determines capacity requirements for raw materials, intermediates, and product.
4. Supportthe preparation of bill of materials, batch records, SOPs, and close-out reports for each campaign.
5. Provide technical expertise and contribute in troubleshooting product and equipment issues and deviations.
6. Ensure adherence of operations to cGMP, ICH, EMEA and JP Guidelines as well as industry safety standards and OSHA guidelines.
7. Interact cross-functionally with Production Operations, Facilities, R&D, Quality Assurance, Quality Control, Project Management, Procurement, and Finance and other internal and external functions to play a critical role in the support of successful product development.
Education: BS in biological sciences, engineering, business or operations management is a must
Minimum of 3-5 yrs in a multi-discipline cGMP environment, commissioning and running equipment in Support production areas.
Minimum of 1-2 yrs experience in SAP at a pharmaceutical or bio-technology company preferred.
Knowledgeable in the operation of area specific production equipment for media and buffer manufacturing.
Must be willing to work any shift in supporting 24/7 bulk operations that may include weekends, holidays and overtime, as required.
Must be able to sit and/or stand for extended periods of time and be able to lift 25 lbs.
Self starter with a strong focus on detail, safety, quality and results.
Ability to multi-task and adjust to varying priorities to meet timelines.
Ability to identify, investigate, and trouble-shoot basic process and equipment problems.
Working knowledge of cGMP, EMEA, and JP regulations.
Good written and communication skills.
Good problem solving and interpersonal skills with the ability to work in a team environment required.
Eisai is committed to a policy of equal employment opportunity for all employees and applicants. The Company also strives for a work environment free from discrimination and harassment. It is Eisai s policy to comply with all applicable federal, state and local laws and regulations regarding nondiscrimination in employment and not to discriminate against any employee or applicant for employment on the basis of any protected status, including, but not limited to, race, color, national origin, religion, sex, age, disability, pregnancy, ancestry, creed, alienage or citizenship status, sexual orientation, gender identity and expression, marital status, military/veteran status, genetic information, or any other protected characteristic as established by law.
Eisai is an Equal Opportunity Employer Minority / Female / Disability / Vet