Process Engineer I

Waltham, MA, United States

Summary

A Process Engineer is responsible for ensuring operability and reliability of GMP manufacturing process equipment located at manufacturing facilities. This Candidate provides process engineering service support and coordinate various engineering activities with outside groups (e.g., Manufacturing, Facilities, Validation, Quality). This individual will also work closely with Equipment SMEs, MS&T and equipment End Users to investigate and troubleshoot issues related to process equipment.

Responsibilities

Installation and startup testing of new equipment (generation, execution, and close out of engineering test plans)

Ownership of system P&IDs – responsible for engineering review, walkdowns, redlines & system changes.

Generation, review, and approval of engineering lifecycle documentation for assigned systems.

Review, approval, and execution support of C&Q protocols for assigned systems.

Generation, review, and approval of engineering change management for assigned systems.

New systems troubleshooting floor support.

This individual will work closely with Equipment SMEs, MS&T and equipment End Users to investigate and troubleshoot issues related to process equipment.

Provide direct engineering support and Subject Matter Expertise for process equipment such as: (Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc...). This includes serving as the Engineering owner for process equipment.

Skills required to meet expectations of the role include high-quality technical writing within the required quality systems and meeting the project timelines to ensure the production schedule is not impacted.

Provide daily, on-the-floor support to manufacturing.

Facilitate tech transfer, process fit, and facility fit for new projects.

Support the team goal of achieving gold standard batches and right the first-time processing.

Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, owning Corrective/Preventative Actions and associated change controls.

Own quality records such as Change Controls, Deviations, and CAPAs, related to manufacturing process equipment, as required.

Provide input into preventative maintenance plans, assessing change controls, and continuous improvement initiatives.

Other duties as assigned

Skills and Qualifications

0-3 Years experience in a GMP manufacturing/engineering environment and a B.E. / B.S. degree in Chemical Engineering.

Must have previous Biotech or Biopharmaceutical industry experience working in a process engineering role

Must have strong knowledge and experience supporting cleaning (CIP, COP, glass washers, detergent distribution), sterilization (SIP, autoclaves), bench‐top analytics (Cedex, Nova, filter integrity testers), and single‐use systems.

Good report and technical writing skills with the ability to drive changes in a cross-functional team environment

Experience with all aspects of biotech and pharmaceutical industries.

Demonstrates good interpersonal skills, is attentive and approachable.

Maintains a professional and productive relationship with area management and co-workers.

Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.

Additional Skills Required:

In order to perform a client assignment for DPS successfully, an individual must be able to perform each essential duty to high technical standard. 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.

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.

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

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.

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.

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.

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

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.

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.

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.

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