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505-207-7740

The Sr. Process Engineer provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
Summary:
The Process Engineer/Specialist is responsible for the technical support (equipment, process, employees’ knowledge base, LEAN and improvements) of specifically their assigned area. They also support other members of the group by assisting in technical support in all areas of the facility. Process improvements are conducted through the use of Lean Six Sigma (LSS) tools/process. This position must be able to effectively manage, lead, and problem solve both technically and managerially in a dynamic manufacturing setting.  They are responsible for completing change controls related to Manufacturing Batch Records, SOPs, equipment changes, new products and process changes. Process Engineer/Specialist is required to have a general working knowledge of the facility as a whole.
Essential Duties and Responsibilities include the following:
• Responsible for leading the tech transfer of client processes and executing engineering functions including design and document controls.
• Identify and specify process specific equipment needed for client tech transfer.
• Author instructions for the operation of equipment and for detailing process flows in clean room facility.
• Develop new manufacturing and aseptic filling processes to meet client requirements.
• Ability to troubleshoot, amend and accommodate the process of aseptic formulation and fill of drug product such that it harmonizes with HCM Manufacturing Facility while protecting the integrity of client technology / product.
• Develop batch records and write reports.
• Perform aseptic processing operations including equipment preparation and sterilization, aseptic assembly, bulk substance formulation and sterile filtration, to support manufacturing.
• Execute Engineering functions for all quality system elements, including CAPA’s, DR’s, Change Controls, Design Controls and Document Controls. Specify and procure new process specific equipment.
• Work with vendors to manufacture new process equipment as necessary. Maintain contact and good working relationships with clients.
• On Call 24/7.
• Other duties as assigned Supervisory Responsibilities:
This job has no supervisory responsibilities.

Qualifications

Education and/or Experience:
• Educational Qualification
• B.E. Chemical
• Experience
• 15+ years in similar kind of industry.
• Meticulous and highly organized.
• Excellent communication skills.
• Must have Aseptic technique, familiarity with clean room personnel flows.
• Desired
• Knowledge of process flows – i.e. Bio disposables strategies, filtration, mixing strategies, fluid transfer to and from various vessels/bio bags.
• Desired
• Working knowledge of process engineering processing aids such as sanitary connections, valves and pharmaceutical process design.
• Experience with SIP a plus.
• Computer literate with good working knowledge of spreadsheet software (Visio or equivalent drawing program a plus).
• Ability to work with minimal supervision and interact well with clientele as well as interdepartmentally. Language Skills:
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.  Ability to write reports, business correspondence, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.  Mathematical Skills:
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.  Ability to apply concepts of basic algebra and geometry.
Reasoning Ability:
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Ability to write reports, business correspondence, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.  Mathematical Skills:
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.  Ability to apply concepts of basic algebra and geometry.
Reasoning Ability:
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

To apply for this job please visit pharmaboard.com.