43 applicants
Formulated Solutions · 1 week ago
MS&T Process Engineer
Largo, FL
Full-time
Onsite
Mid Level
2+ years exp
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Hiring Manager
Sandra Floyd
Insider Connection @Formulated Solutions
Responsibilities
Independent management of product transfers, performing equipment fit and gap analyses, and authoring critical documentation such as Risk Assessment, OOS Investigation, Process Validation protocols, Cleaning Validation protocols, etc.
Focused on process optimization in all phases of the manufacturing process (blending, filling, packaging, etc) using lean or six sigma tools for optimal impact.
Lead and/or support cleaning validation and process validation efforts and projects, as needed to support commercial operations.
Identify and lead continuous improvement engineering projects to enhance process robustness, manufacturing efficiency, and deviation reduction through engineering controls.
Generate technical reports, specifications, and other supporting documentation as needed.
Coordinate with outside vendors, contract labs, and equipment manufacturers as needed to support project or related work deliverables.
Provide day-to-day technical support for commercial manufacturing. Conduct technical investigations, write reports, and aid in the close-out of deviations.
Support business with strategic analysis and proactive concept development for manufacturing process optimization projects.
Collaborate across various departments like Manufacturing, Quality, R&D teams, Engineering, and Project Management to ensure project success.
Generate/maintain documents and provide related technical support related to GMP Manufacturing executions, product impact assessments, and periodic reviews.
Participate in the project team meetings, decisions, and creation of milestones representing process engineering.
Process training, as needed, in adherence to company policies and quality requirements.
Evaluate, define, and provide user requirements for process equipment associated with drug product manufacturing.
Prepare and present data associated with manufacturing processes to internal and external teams as required.
Keep current on regulatory and quality requirements for manufacturing, including FDA-regulated products and cGMP compliance.
Interact regularly with senior technical peers and colleagues.
Perform other functions as required to support existing operations and client-driven projects.
Qualification
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Required
Bachelor’s degree in chemical engineering or relevant experience
At least 2 years of process engineering/technical services/MS&T experience (preferably 5 years) in the pharmaceutical/chemical manufacturing industry, preferably with cGMP manufacturing of FDA-regulated drug products
Demonstrated ability for independent work, thought, and analysis
Ability to coordinate with internal groups as needed to achieve desired goals and deliverables (Manufacturing, Engineering, Supply chain, QA, QC, R&D, Project Management, etc.)
Exceptional time management and multi-tasking skills
Excellent written and verbal communication skills with expertise in good documentation practices
Ability to perform statistical analysis of data and interpretation of data
Must be capable of detailed record keeping and communicating results to others
Preferred
Experience with pharmaceutical and consumer products related to creams, lotions, liquids, aerosols, nasal sprays, and/or gels is a plus
Cleaning validation experience is strongly preferred
Process validation experience is strongly preferred
Minitab experience is preferred but not required
Company
Formulated Solutions
Formulated Solutions is a manufacturing organization for contract development.
501-1,000 employees
H1B Sponsorship
Formulated Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (1)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2014-03-28Private Equity· Undisclosed
Leadership Team
Eric Dann
Founder and CEO
Recent News
Fierce Pharma
2023-10-10
2022-12-21
Company data provided by crunchbase
