- Seeks solutions that strengthen quality, value, service, and effectiveness.
- Demonstrates functional/technical proficiency, engages in effective operational and strategic planning .
- Translates goals/objectives into actionable plans and results.
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Process Engineer
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Catalog Boston, United StatesCATALOG, a Boston-based pioneering startup, is making significant strides in the field of data storage and computation by harnessing the power of DNA. DNA, known for its millennia-long stability, unrivaled information density, and cost-effective replicability, offers revolutionar ...
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5 days ago
Catalog Boston, United StatesCATALOG, a Boston-based pioneering startup, is making significant strides in the field of data storage and computation by harnessing the power of DNA. DNA, known for its millennia-long stability, unrivaled information density, and cost-effective replicability, offers revolutionar ...
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Senior Process Engineer
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Senior Process Engineer
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Manger of Process Engineering
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Senior Process Engineer - Boston, United States - Katalyst Healthcares and Life Sciences
Description
Responsibilities:
Execute change management for manufacturing equipment and other support systems including commissioning and/or implementation of other related initiatives as assigned.
Execute assigned duties on time and within budget; pro-actively communicate delays and other issues to relevant stakeholders.Manage creation and revision of protocols, reports, and engineering documents including, but not limited to, IOV, drawings, user requirement specifications and SOP's.
Effectively work with cross departmental stakeholders to achieve departmental goals and objectives.Supply GEP (Good Engineering Practice) expertise drawn from own experience and/or supplemented by external resources to trouble shoot facility, equipment, or system issues.
Balance the degree of innovative exploration with pursuit of project objectives and coordinates implementation / integration of new capabilities as appropriate.
Requirements:
B.A, B.S. in Engineering or related discipline with at least 5 years of relevant experience or M.S. in related field with 3 years of experience. Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI. Knowledge of facility-related engineering disciplines (MEP) in GMP manufacturing environment, preferably oral solid dosage, or related experience. Extensive hands-on experience dealing with change controls. Excellent verbal and written communication skills applied on a global or multi-national basis. Strong interpersonal skills, including the demonstrated ability to manage through influence. Demonstrate planning and organizational skills, including complex project management. Experience in the areas of Design Documentation (URS, FRS, DS, and other engineering specifications), Validation (IQ, OQ, PQ, PV, CSV, MVP, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc) Foster change and innovation