Aveva Drug Delivery Systems

About Aveva Drug Delivery Systems

MANUFACTURING ENGINEER Direct Reports 1-3 Job Summary This person is responsible for the design, purchase, installation and operation of all equipment directly used in the scale-up and production of their coating/finishing into laminate form. This person is responsible for the design, purchase, installation and operation of all equipment directly used in the scale-up and production of their coating/finishing into laminate form. Job Responsibilities Manage projects involving installations and upgrades of equipment for adhesive blending and coating. Assure that maintenance support and training, and operator training are sufficient to operate process equipment efficiently. Interface with operating production and R&D management to schedule current projects. Assist R&D personnel during scale-up with equipment planning and operating issues. Perform investigation of production problems, identify and complete CAPAs. Responsible for supporting GMP documentation required modifications to existing equipment and new equipment including creation or revising User Specification Requirements, Commissioning protocols, Work Instructions, Training material and co-generation of Standard Operating Procedures, Safety procedures (Loto, ect). Support process equipment on a rotating on-call basis and by phone whenever needed. Works as a member of a team to achieve all outcomes Performs all work in support of our Corporate Values of Pride, Accountability, Intergrity and Diligence; Demonstrates strong and visible support of our values Performs all work in accordance with all established regulatory and compliance and safety requirement All other duties as assigned Manage projects involving installations and upgrades of equipment for adhesive blending and coating. Assure that maintenance support and training, and operator training are sufficient to operate process equipment efficiently. Interface with operating production and R&D management to schedule current projects. Assist R&D personnel during scale-up with equipment planning and operating issues. Perform investigation of production problems, identify and complete CAPAs. Responsible for supporting GMP documentation required modifications to existing equipment and new equipment including creation or revising User Specification Requirements, Commissioning protocols, Work Instructions, Training material and co-generation of Standard Operating Procedures, Safety procedures (Loto, ect). Support process equipment on a rotating on-call basis and by phone whenever needed. Works as a member of a team to achieve all outcomes Performs all work in support of our Corporate Values of Pride, Accountability, Intergrity and Diligence; Demonstrates strong and visible support of our values Performs all work in accordance with all established regulatory and compliance and safety requirement All other duties as assigned Job Requirements Current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA), Pharmaceutical Manufacturing SOPs and other regulatory requirements. Business English usage, spelling, grammar and punctuation. Basic mathematical and statistical computation methods and practices. Skill in: Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquires or complaints from regulatory agencies, or members of the business community. Ability to effectively present information to management. Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, DOE, RCM (Reliability Centered Maintenance), analysis of variance, correlation techniques, sampling theory, and factor analysis. Minimum Qualifications: B.S. Engineering degree and four to ten years related experience and/or training; or equivalent combination of education and experience. Additional Information: Available for On Call Non-working hours. Support hours actually worked during off-hours may vary from 4 hours minimum to 12 to 38 average/month. Current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA), Pharmaceutical Manufacturing SOPs and other regulatory requirements. Business English usage, spelling, grammar and punctuation. Basic mathematical and statistical computation methods and practices. Skill in: Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquires or complaints from regulatory agencies, or members of the business community. Ability to effectively present information to management. Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, DOE, RCM (Reliability Centered Maintenance), analysis of variance, correlation techniques, sampling theory, and factor analysis. Minimum Qualifications: B.S. Engineering degree and four to ten years related experience and/or training; or equivalent combination of education and experience. Additional Information: Available for On Call Non-working hours. Support hours actually worked during off-hours may vary from 4 hours minimum to 12 to 38 average/month. Job Type: Full-time Additional Compensation: Bonuses Work Location: One location Benefits: Health insurance Dental insurance Vision insurance Retirement plan Paid time off Parental leave Schedule: Monday to Friday Overtime

Synonyms

Technologies (from Job Ads)

Hiring Locations

Headquarters

Loading map...

Company Info

Legal Form: Inc

Company Type: Private

Company Size: 51 - 250

Revenue: 100 - 500 million (USD)

Job Ad Metrics

Job Ads found: 39

Job Ads per Month: 2.1

Hiring Locations: 2

Data Info