Job Information
PCI Pharma Services Formulation Technician I in Bedford, New Hampshire
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.
JOB SUMMARY
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.
JOB DUTIES
- 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.
EDUCATION
- High School education or AS degree or BS degree in Chemical Engineering/ Bio Chemistry or other industry related discipline is preferred
EXPERIENCE
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
PROFESSIONAL SKILLS
Strong interpersonal skills
Strong working knowledge of MS Office suite is preferable
QUALITIES
Attention to detail and positive attitude are key attributes
Able to follow rules and regulations perfectly
PHYSICAL REQUIREMENTS
Able to stand for long periods of time, the majority of the work shift
Able to lift 30lbs repeatedly
Able to wear PPE (mask, gloves, respiratory)
COMMUNICATIONS & CONTACTS
- Works directly with aseptic and non-aseptic personnel. Works closely with Quality Assurance, MTS, Validation etc.
TRAVEL < 10%
#LI-HA1
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled