Process Engineer II - United States
What differentiates us at Alcami? Our people.
Help shape the future of medicine and join us – we are a pharmaceutical contract development manufacturing organization (CDMO).
Alcami Corporation is the first company to offer a solution that is tailored to small and mid-size pharmaceutical and biotechnology companies. We offer a range of services from four distinct pillars: Development Services, Analytical Testing, Drug Product, and APIs. Beyond that, we can integrate our services so customers experience a simplified engagement with a single project management relationship, full visibility from development into manufacturing, and shorter turnaround times. With six locations in the U.S. and a global location in The Netherlands, the Alcami family is growing rapidly. Picture yourself at Alcami and apply today.
Position Overview: A Process Engineer II is responsible to provide technical support for the packaging of tablets and capsules in bottles and blisters for commercial distribution and clinical trials. Personnel in this position will provide technical assistance including but not limited to the following: transfer of new process and technologies into the company and writing appropriate documentation to support process transfer and validation activities, sourcing and qualification of equipment and components, troubleshooting current validated processes, initiate process deviations and conduct investigations. These functions will be executed following standard operating procedures, batch records in accordance with FDA and EU current Good Manufacturing Practices, and federal regulations. Will train and mentors others in the organization.
As the Process Engineer II, you will:
- Provide technical assistance for process transfer, start-up and validation for assigned packaging projects.
- Composes process validation, cleaning validation, or process optimization protocols.
- Assists with identification, selection, sourcing, installation and qualification of packaging equipment and supporting utilities & systems. Designs and or modifies equipment and fixtures for packaging.
- Originates and executes packaging process validation, equipment cleaning verification & validation, or process optimization protocols and completes final reports.
- Clearly and accurately document activities.
- Perform basic to moderate math calculations.
- Identify specific process parameters, product sampling plans, and product tests used in the validation protocols of new and existing products.
- Write validation and technical improvement reports with no approval authority.
- Provides input or originate as required Master Batch Records (MBRs) and in-process controls for products, equipment, critical process parameters, in-process tests, etc.
- Monitors packaging processes during initial production run to assess any technical process issues.
- Assist technicians in performing packaging tasks and related physical testing during the packaging operation (e.g. torque studies, cap closing force checks, seal integrity testing, etc.).
- Participate in investigations and complete CAPA assignments.
Qualifications for success:
B.S. in Engineering, Pharmacy or Chemistry or another degree deemed appropriate.
3-7+ years in pharmaceutical manufacturing environment or equivalent regulated industry.
- Good understanding of packaging of solid dose manufacturing.
- Good understanding of the basic principles of technology transfer, process investigations, scale-up, process validation, and optimization of solid dosage forms spanning the entire product life-cycle.
- Good understanding of applicable SOPs.
- Good understanding of safety policies.
- Good verbal and written communication skills.
- Safety - Ability to wear Personal Protective Equipment (including gowning and powered respirators). Understands and follows safety procedures and works in a manner to avoid injury to self and co-workers. Willingness to work with highly toxic and controlled materials.
- Quality Control – Quality Control – Ability to work with QA to effectively resolve issues and maintain an environment that is of the highest quality.
- Regulatory Compliance – The ability to work in a regulated environment (FDA / DEA / OSHA) and strictly follow procedures.
- Communication - Effective verbal and written communication. Ability to read and comprehend detailed written instructions.
- Documentation – Clearly and concisely documents all work activities in a timely manner and writes appropriate reports.
- Data Handling –Some advanced computer skills (Excel, PowerPoint). Strong analytical skills. Collect data, evaluate its relevancy, conduct comparative and statistical evaluations and present it in a professional manner including graphs and charts.
- Client Interaction – Interacts with clients on a regular basis.
- May directly interact with auditors during scheduled inspections.
- Teamwork – Ability to work effectively within a team environment. Capable of working across boundaries in the organization.
What we offer you:
- Profit sharing bonus plan
- Medical, dental and vision coverage from day one
- A menu of voluntary benefits including short & long term disability, life, accident, critical illness and hospital indemnity insurances
- Paid/flexible sick-leave, vacations, and holidays so you can take the time when you need it
- To complement your personal financial strategy, we also have 401(k) matching