Job Description

Job Title: Associate Engineer, Biotech (JP10225)
Location: Thousand Oaks, CA.
Employment Type: Contract
Business Unit: DP Process and Equipment Capabilities
Duration: 3 years with likely conversion to permanent.
Posting Date: 5/10/2022

3 Key Consulting is hiring an Associate Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.

As a member of the process development team, this role will be focused on characterizing new fill finish technologies and advancing the state of the drug product manufacturing process. The candidate will be primarily responsible for executing filler characterizations studies using complex fillers organizing data and analyzing results with minimal supervision.

The candidate will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, analyze data and communicate results to cross functional groups.
Engineer responsibilities include, but are not limited to, the following:

Independently design and execute experiments in order to characterize and enable implementation of new capabilities such as filling, lyophilization and analytical technologies
Serve as single point of contact and subject matter expert (SME) on complex capabilities.
Own business process and responsible for maintaining line time request forms and metrics
Apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials
Conduct analysis of data generated from any of the above listed activities, including statistical analysis using SAS, JMP etc., and effectively communicate results
Troubleshoot malfunctioning equipment, work with system owners, Asset Management, Facilities and vendors to repair
Author/review technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures
Perform tasks related to safety and compliance initiatives in the lab.
Manage procurement and inventory levels of commonly used lab supplies and chemicals
Manage dynamic project schedules and timelines

Preferred Qualifications:

B.S. with 2‒3 years of industry experience, M.S. with 1‒2 years’ experience, with degree in Engineering
Previous experience in drug product/ drug substance manufacturing or process development labs
Knowledge of and hands-on experience with various drug product technologies, particularly filling technology

Displayed critical thinking, problem solving and independent research skills
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Good computer and organizational skills with strong attention to detail
Excellent communication (oral and written)
Excellent project management skills including the ability to manage project resource requirements material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management
Self-motivation, adaptability and a positive attitude
Ability to work independently and as part of a team with internal and external partners
Experience working in GMP environments or process development
Light to moderate lifting and carrying of 15-44lbs, reach above and below shoulder height. Need color perception/discrimination, far vision correctable with eye glasses

Why is the Position Open?
Staff Augmentation

Top Must Have Skills:

Experience with authoring and reviewing SOPs
Experience with large molecule proteins
Prior experience with filling equipment preferred but not required.

Day to Day Responsibilities:
Support of B6 Pilot plant to operate commercial filling equipment for tech transfers to clinical and commercial sites.

Employee Value Proposition:
The person in this role will work with large molecule proteins and learn how to perform technology transfers. This team works with clinical sites and does clinical fill transfers. You will learn cross functional collaboration through working with many teams.

Red Flags:
Candidates who intend to apply for graduate school in the short future
Many jobs within a short period of time

Interview process:
1) Phone (30 mins)

2) Virtual with team (1-2 hrs)

3) Possible on-site with team (2-3 hrs)

About 3 Key Consulting, Inc.

3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries. With 12 years of experience, 3Key has established a vast network of industry professionals and forged strong partnerships/alliances with key academic institutions across the country to continually develop our business professional and niche skill pipeline.

3KC offers a full suite of staffing solutions including PEO and compliance services. 3KC has several technology and industry domain practices including competencies in business intelligence, healthcare and life sciences.

People, process, and technology are 3 key areas of focus that we carefully examine individually and jointly, in order to deliver on our client's 3 key areas of focus - better, faster and cost effective BI and staffing solutions.

MISSION:

To create a better work experience for our customers, partners and employees through exceptional dedication and performance.

• We make hiring easier

• We build strong teams

• We bring about positive outcomes

VISION:

3 Key Consulting’s responsibility is to continually improve the manner and efficiency in which human resources and businesses are brought together to create value. Our vision is to put programs into action that improve market efficiencies while helping businesses and people be more productive.

Industry

Unknown

Company Size

1-10 employees

Headquarters

Simi Valley, CA

Year Founded

2009

Website

3keyconsulting.com

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