Job Description

Summary

Arcadis DPS Group is seeking a Project/Site Engineer to support a client in Boston (Seaport), MA. The Site Engineer is responsible for providing Engineering support function for client’s GxP Facilities Operations. The qualified candidate will report to the Senior Specialist, GxP Site Engineering. The role will provide technical support, including drawing review, design review, specification review, project management, change management and commissioning for GMP manufacturing equipment and facilities in a manner compliant with regulatory expectations, company policy and current procedures.

Responsibilities

• Execute change management for manufacturing equipment and other support systems including commissioning and/or implementation of other related initiatives as assigned.
• Execute assigned duties on time and within budget; pro-actively communicate delays and other issues to relevant stakeholders.
• Manage creation and revision of protocols, reports, and engineering documents including, but not limited to, IOV, drawings, user requirement specifications and SOP’s.
• Effectively work with cross departmental stakeholders to achieve departmental goals and objectives
• Supply GEP (Good Engineering Practice) expertise drawn from own experience and/or supplemented by external resources to trouble shoot facility, equipment or system issues.
• Balance degree of innovative exploration with pursuit of project objectives and coordinates implementation / integration of new capabilities as appropriate.
• Managing schedules and contractors as needed depending on the project and working with other stakeholders to plan and schedule work around manufacturing schedules

Skills and Qualifications

• Approx. 3-5 years in a GMP environment in biotech/pharmaceuticals.
• The role will require knowledge of many different facility systems including: Clean utilities (water systems and gases), HVAC controls experience and familiarity with BMS/EMS systems
• Excellent written skills. Can write clearly and effectively without requiring major corrections or oversight. Ability to convey complex processes in straightforward language
• Experience writing change controls for biotech (biologics preferred) in an electronic Quality Management System such as Veeva or Trackwise
• Ability to read and interpret complex technical documents, such as experimental protocols and reports, manufacturing batch records, and regulatory filings
• Strong sense of ownership. Role requires following up with stakeholders to ensure assessments and tasks have been completed.
• Problem solving and conflict resolution skills. Experience removing roadblocks and facilitating solutions.

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.

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

Arcadis 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.

Arcadis 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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