Alcami

Process Engineer II

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Job Description

The Process Engineer II (Sterile) for our parenteral site in Charleston, SC is accountable for driving results in a fast-paced environment by providing provide operational support to key process service areas (equipment/systems) in the manufacturing of commercial and clinical products at Alcami MA sites. Project engineering activities associated with technology transfers (feasibility, facility fit assessment, user requirements, process description, change control ownership, commissioning test plans, training). The Process Engineer II will be part of a dynamic group of engineers who will be responsible for trouble shooting, determining root cause of problems and providing process optimization strategies and process support within multi-product, FDA regulated cGMP facilities. All system improvements will be made in conjunction with Manufacturing, Facilities, Manufacturing Technical Services, Quality Assurance, Validation and Regulatory.  The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions

Provides technical assistance for process transfer and validation efforts for assigned manufacturing.
Composes process validation, cleaning validation, or process optimization protocols
Identifies specific parameters, sampling, and tests used in the validation protocols of new and existing products.
Writes validation and technical improvement reports with no approval authority.
Writes Master Batch Records with a strong understanding of (equipment, critical process parameters, in-process tests, etc.).
Monitors manufacturing processes during initial production run to assess any technical process issues.
Assists technicians in performing physical testing during manufacturing operation (e.g compounding of product).
Participates in investigations and complete CAPA assignments.
Utilizes FMEA aid in the development of a control strategy.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
On call support 24/7
Keeps abreast of advancement in new technologies
Provides peer review for deviations/investigations.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Education and Experience

Bachelor’s degree in Engineering, Pharmacy or Chemistry with a minimum of 3 years of experience of technical support in a sterile pharmaceutical manufacturing environment preferred.
Alcami Non-Negotiables

Consistently demonstrates honesty and integrity through personal example.
Follows all safety policies and leads by example a safety first culture.
Produces high quality work product with a focus on first time right.
Complies with the company code of conduct and policies and regulatory standards.
Alcami Core Leadership Competencies

Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.
Travel Requirements

Up to 5% travel required.

Diversity and Inclusion:

Alcami values diversity and we are committed to creating an inclusive environment for all employees.   All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.

Job Summary

wave-1-bottom
Charleston, SC Location
Full Time Job Type
Alcami

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