Technical Operations Change Control Specialist

4 weeks ago

Boston, United States DPS Engineering Full time

Summary

Arcadis DPS is looking for a Technical Operations Change Controls Specialist for a client in Boston, MA.

Responsibilities

* Initiate the change control process. Gather information from the requesting department, bring information to the change control committee for endorsement, initiate the change control record in eQMS describing the change and the justification, drive the completion of the assessments, drive the agreement to the tasks, follow up on the completion of the tasks, submit the required documentation to close out the change control
* Work with technical SMEs (Regulatory, Engineering and Facilities, Manufacturing Science and Technology, Process Development, Supply Chain, Validation) to ensure the appropriate stakeholders are involved in the assessment of the change control and completion of the tasks
* Ensures the change controls are written to the best standards, with appropriate detail for review by regulatory agencies during audits
* Scope of change controls includes but not limited to: Introduction of new process equipment, changes to existing process equipment, technical transfer of new process from Process Development to Manufacturing, tech transfer between manufacturing sites, changes to existing process, scale-ups, changes to Raw Materials, introduction of new programs/strategies.
* Present change controls in the change control review board (CCRB) forum.
* Verify the impact of the change on regulatory filings.
* Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across CMC.
* Negotiate with QA partners: discuss requirements, ensure the documentation is completed appropriately for closure, etc.
* Establish and manage the timeline for completion of the tasks. Follow up with the task owners to ensure that the change control does not become overdue.
* Escalate any risks or issues encountered during the execution of the change control

Skills and Qualifications

* Approx. 5-8 years in a GMP environment in biotech/pharmaceuticals. Preferably as a manufacturing specialist, MSAT/PD, process engineering, or QA specialist
* Experience writing change controls for biotech (biologics preferred) in an electronic Quality Management System such as Veeva or Trackwise
* Experience with tech transfer process. Understands the different purposes and cGMP requirements for pilot runs, engineering runs, PQ runs etc.
* Excellent written skills. Can write clearly and effectively without requiring major corrections or oversight. Ability to convey complex processes in straightforward language
* 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

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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