Specialist Manufacturing #26-24775

Duration: 14-months contract
Shift: Available to work various shifts (day swing graves weekends holidays 5x8hrs 4x10hrs)

Job Description:

• The ideal candidate for the Manufacturing Specialist role will have at least 1 year of relevant experience in a biotech or pharmaceutical manufacturing environment with a strong preference for those with upstream operations experience.
• This position supports manufacturing from a process owners perspective so candidates should be comfortable working onsite Monday through Friday with occasional flexibility for non-standard hours (including weekends) based on implementation needs. While some remote administrative work (e.g. SOP revisions tracker updates) may be allowed onsite support is expected.
• Candidates should demonstrate a go-getter attitude strong adaptability to changing priorities and a willingness to ask questions and escalate when unsure.
• Familiarity with project management as well as tools like Smartsheet and Excel is highly desirable but not required.

Responsibilities include:

• Support manufacturing by providing subject-matter expertise for Drug Substance Upstream and Downstream processes as Process Owner (PPO).
• Lead cross-function and complex projects using project management skills.
• Resolve quick issues and lead troubleshooting including execution of function tests to troubleshoot and optimize process.
• Write protocols and reports in support of validation function testing equipment commissioning and qualification and change management.
• Own Quality Records such as CCMS CAPA and CAPA-EV.
• Apply technical process scientific operational and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant.
• Demonstrate strategic problem-solving skills and champion continual improvement.
• Available to work various shifts (day swing graves weekends holidays 5x8hrs 4x10hrs) as instructed by the production schedule to execute function-testing and project tasks with minimal disruption to operations.
• Must be able to work in a clean room environment wearing steel toe shoes full clean room gowning hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance.

As Process owner:

• Support operational readiness of new technologies equipment or processes by applying technical process scientific operational and compliance knowledge with project management skills
• Develop/own drug substance manufacturing processes and procedures. Draft and revise GMP manufacturing documents (SOPs Forms).
• Draft and develop user requirements for new technologies.

Preferred Qualifications:

• Degree in Engineering or Life Sciences
• 3 years or more experience in Drug substance GMP technical support roles GMP manufacturing Engineering Process Development or equivalent.
• Technical knowledge of drug substance processing and broad understanding of related disciplinary areas
• Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
• Ability to navigate through ambiguity and identify and deliver on key milestones.
• Ability to advise and influence using experience and data.
• Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
• Data analysis and/or data visualization skills
• Proficiency in Smartsheet and excel Trackwise visio pi SAP spotfire

Must Have Skill Sets:

• Go getter attitude
• Ability to adapt to changing priorities
• Manufacturing experience

About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions please visit .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race colour religion sex sexual orientation gender identity national origin disability or status as a protected veteran.

AI Statement: By applying you acknowledge that AI-assisted tools may be used during hiring.

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Required Experience:

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