Formulation Technician I

PCI Pharma Services•Bedford, NH

About The Position

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. This position will have the primary responsibility for daily formulation activities to ensure schedule activities are completed, formulation materials and equipment are maintained, as well as the responsibility for performing corrective and preventative actions. As a secondary function, provide troubleshooting expertise for manufacturing of products both internally and externally of the company. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned. Has ownership for the daily formulation activities to ensure scheduled all scheduled tasks/events are completed Is responsible for critical steps in the formulation process including but not limited to, lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or finical loss Initiate the production of batch documentation used for engineering and cGMP production. Prepare and update Master Production Batch records and SOPs accurately for communicating and initiate the documentation change process for needed documentation changes Complete executed Batch Records accurately and completely prior to submission to supervision for review Comply with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements Author process deviations when these occur within the department, participate in investigations, and contribute to identifying corrective and preventative actions Cross train to increase technical skills across the department Accountable for timely communication to management and clients of issues, challenges as well as opportunities for process improvements. As a member of the manufacturing team, you will perform other manufacturing tasks for example filling, capping etc., as needed. Work with enabling groups to improve/implement processes. Other duties as assigned. Strong interpersonal skills Strong working knowledge of MS Office suite is preferable Attention to detail and positive attitude are key attributes Able to follow rules and regulations perfectly Works directly with aseptic and non-aseptic personnel. Works closely with Quality Assurance, MTS, Validation etc.

Requirements

Required: High School education or AS degree or BS degree in Chemical Engineering/ Bio Chemistry or other industry related discipline is preferred
Experience and knowledge of formulation/compounding tools and equipment
Minimum 1-2 year’s work experience in a GMP environment preferably in fill finish pharmaceutical operations
Demonstrated ability to prioritize multiple projects and activities
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
Strong interpersonal skills
Strong working knowledge of MS Office suite is preferable
Attention to detail and positive attitude are key attributes
Able to follow rules and regulations perfectly
Works directly with aseptic and non-aseptic personnel.
Works closely with Quality Assurance, MTS, Validation etc.

Responsibilities

Has ownership for the daily formulation activities to ensure scheduled all scheduled tasks/events are completed
Is responsible for critical steps in the formulation process including but not limited to, lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or finical loss
Initiate the production of batch documentation used for engineering and cGMP production.
Prepare and update Master Production Batch records and SOPs accurately for communicating and initiate the documentation change process for needed documentation changes
Complete executed Batch Records accurately and completely prior to submission to supervision for review
Comply with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements
Author process deviations when these occur within the department, participate in investigations, and contribute to identifying corrective and preventative actions
Cross train to increase technical skills across the department
Accountable for timely communication to management and clients of issues, challenges as well as opportunities for process improvements.
As a member of the manufacturing team, you will perform other manufacturing tasks for example filling, capping etc., as needed.
Work with enabling groups to improve/implement processes.
Other duties as assigned.