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Please note this is a 18 month contract position. Hours are typically 8am - 5 pm.The role is on-site (not remote). This position may require up to 10% domestic and international travel.
Minimum QualificationA Bachelor’s degree in chemical engineering or related field is required. A Master’s degree is preferred.Generally 6 years of experience in an industrialized manufacturing environment involving pharmaceuticals chemicals is required (minimum 4 years with Master's degree in relevant field).Experience in Small Molecule API business is preferred.Experience in chemical manufacturing processes, technologies and products is required.Project management, organizing, planning and coordination skills is preferred.Strong mind-set and knowledge of Quality and Compliance regulatory requirements (GMP EHandS) is required.Use and application of process excellence, statistics, lean production concepts.Strong business insight and understanding of financials is preferred.Ability to seek innovation and change to ensure competitiveness is preferred.Strong communication skills (influencing, negotiating, handling conflicting interests) are required. Affinity with data analytics tools is preferred.Operations Technical Operations Process Specialist:- BS in Engineering Discipline, Chemical Engineering preferred or Chemistry with generally 6 years experience. A representative job description is attached.- Creates and maintains technical documentation such as batch production records, operating procedures, validation protocols and reports. Collects and analyzes process data. - Supports day to day base business in Operations and Technical Operations.Essential Job Duties and ResponsibilitiesThe Operations Technical Operations Process Specialist is responsible for the API manufacturing processes and intermediates they support. They provide technical support for processes including performing analysis to measure process performance, troubleshooting, and implementing improvements in process cycle time, yield, and quality to maximize operational efficiency. They further support introduction and validation of new and existing products.Key Responsibilities:Provides day to day support of assigned processes. Creates and maintains production documentation such as batch records, operating procedures, protocols and reports.Conduct and or participate in problem solving efforts and plant investigations by analysis and correction of both process and equipment problems to maintain or improve existing site operations.Responsible for process surveillance programs on issues such as process control, yields, cycle times, quality, and change over. Prepare written interpretations of plant operating data and implements corrective action.Represent Technical Operations in engineering projects and coordinate small engineering projects. Prepare reports to inform leadership of work in progress with expected completion dates.Lead and execute the process and cleaning validation activities for new and legacy products.Support the introduction of new processes by coordinating and executing the preparation activities for process start-ups and supply technical coverage.Execute cost reduction and efficiency improvement projects using Process or Design Excellence techniques. Utilizes appropriate risk management tools such as FMEA, HAZOP, LOPA and business risk evaluations.Conduct training for operations and maintenance personnel.Maintain knowledge of cGMPs, process safety practices and environmental standards.Additional position requirementsServes in the role of a Owner, Owner Leader or System (equipment) Owner.May represent the Company in international task forcesRequired to produce high quality and accurate work in a timely manner to meet the production schedule.Lead and coordinate multiple projects. Prioritize and work effectively across the organization in completing them on time and in budget.Involvement with PLC’s, DCS BPCS will vary by plant these systems are tools used by the Process Engineer to complete their work.Participate in plant safety programs such as PHA’s for processes to maintain and or improve operational safety.Carry out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Follow all company and site policies and procedures and the intent of our Credo.Assume responsibility for the safety, environmental, quality, and business effects of personal work and of work performed as a team.Successfully complete regulatory and job training requirements.Maintaining proper housekeeping at all times.Be available for overtime work on a scheduled or emergency basis. Travel may be necessary.Other projects or assignments as requested by management.Applicants must include their phone number. Reference job number A1855.