Senior Process Engineer

Summary

DPS Group has an exciting opportunity for a BioPharma Senior Process Project Engineer responsible for equipment commissioning and calibration activities and documentation in a GMP environment. The ideal candidate will have the skill set and technical competency to support project plans, schedules, documentation, facilities and vendor resources. Support processing/lab equipment/instrumentation technical activities aiming at assuring project accuracy and quality from conception to completion.

Responsibilities

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Familiarity with Critical utilities, TFF, Stainless Steel/Hastelloy Portable reactors, Chromatography Skids, Containment expertise, HTHM/Solvent dispensing, Temperature Control Modules, Milling Equipment, Single Use Equipment (Mixers, Inline dilution)

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Work with a cross-functional team of scientists, automation engineers, facilities staff, and operations experts to rapidly respond to evolving GMP manufacturing and laboratory utilization needs for CDMO client projects

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Engage in new product introduction activities such as facility fit analysis, process flow diagram and P&ID development, support MSAT team in equipment selection and unit operation planning.

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Support facility design and capital project execution projects with expert process and technical input.

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Perform functions to provide technical guidance for execution of small projects with no supervision. Make decisions independently and inform Project Leader or Sponsor of actions taken.

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Assemble and lead small project teams for capital project planning and execution

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Engagement with Facilities group to assist with identification, development, planning and delivery of expense projects and management of facilities shutdown activities.

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Proactively looks for and recommends improvements in site processes and procedures.

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Qualify vendor, solicit bids, review bid contents, expedite equipment delivery, equipment problems communication and coordinate vendor equipment startup

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Develop project management and quality project delivery procedures and adhere to relevant policies for interaction with project design (architecture & engineering firms) and delivery partners (construction managers).

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Maintain high degree of familiarity on technology advancements in cell and gene therapy production processes, equipment, instrumentation and systems

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Ability to understand end-to-end business processes, ensure they are optimized, up to standards and security, in compliance with internal and external regulators, and ability to perform process re-engineering

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Strong reporting skills and ability to understand, analyze, and manipulate data to identify trends to share process road mapping for future changes with key stakeholders

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Direct and manage engineers on new product introductions and/or technical transfers to and from the site, including new technologies.

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Direct day-to-day project development plans.

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Evaluation of raw materials, development of process fits, safety and environmental reviews, batch sheet reviews, regulatory and validation compliance, process monitoring and cycle-time studies, deviation investigations and resolution, and development of filing strategies.

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Proven experience in Process Optimization and Improvement, Change Management and Business Analysis

Skills and Qualifications

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B.S. in an Engineering discipline

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Familiar with project identification & development, expedited project delivery approaches

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Ability to combine technical knowledge and project delivery, providing the best possible project outcomes while retaining focus on cost and schedule constraints.

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Strong organizational, interpersonal, speaking and written communication skills

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Prioritizing multiple commitments and technical problem solving aptitude

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Ability to shift priorities according to changes in department/facility needs and actively consider different ideas/approaches/options.

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Ability to provide legal US work authorization documents required.

Additional

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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Continuous Learning –Assesses own strengths and weaknesses. Pursues training and development opportunities. Seeks feedback to improve performance. Shares expertise with others. Strives to continuously build knowledge and skills.

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Culture - Supports a culture of excellence. Contributes to a collaborative environment that rewards teamwork, mentorship, best-in-practice development, and pride in workmanship.

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Customer Services – Displays courtesy and sensitivity. Manages difficult or emotional customer situations. Meets commitments. Responds promptly to customer needs. Solicits customer feedback to improve service.

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Planning and Organizing – Prioritizes and Plans work activities. Uses time efficiently. Plans for additional resources. Integrates changes smoothly, Sets goals and objectives. Works in an organized manner.

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Teamwork – Balances team and individual responsibilities. Contributes to building a positive team spirit. Exhibits objectivity and openness to others’ views. Gives and welcomes feedback. Puts success of team above own interests.

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Use of Technology – Demonstrates required skills. Adapts to new technologies. Keeps technical skills up to date. Troubleshoots technological problems. Uses technology to increase productivity.

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Language Ability - Read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Write routine reports and correspondence. Speak effectively before groups of customers or employees.

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Mathematical Ability - Work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Apply concepts such as fractions, percentages, ratios and proportions to practical situations.

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Reasoning Ability - Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Deal with problems involving several concrete variables in standardized situations.

The Company

DPS Group is a global EPCMV firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a ‘client-first’ mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.

DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.