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.

   

The Manufacturing Specialist I is responsible for providing technical support to the manufacturing team on a variety of not complex tasks in accordance with the expectations of the FDA and other regulatory agencies, with the support of more experienced personnel while following all safety and quality guidelines. The Manufacturing Specialist II collaborates with the Quality, Development units as well as other departments in the Operations area, with support functions, and execution of technical tasks required in the manufacturing processes. This position will be the SME within the operations processes and is expected to take an active role in process improvement.

FUNCTIONS:

Compliance with all GMP work and manufacturing procedures.Drive efforts to address regulatory compliance issues related to productionDrafting and review of low complexity work procedures, and review of manufacturing documentation. Participation in low complexity training.Elaboration with support of quality events to ensure the maintenance of the required quality standard in the manufacturing plant.Executed batch record review.Identify and work on continuous improvement activities, with the objective of optimizing the currently implemented systems to improve time and ensure time and cost savings, while maintaining the required quality standard.Active participation in work teams associated with new production projects and leadership with the support of higher levels, by the department, with the function of identifying Production needs for the project execution, adapting procedures according to annex 1, contact with material suppliers in case it is necessary.Support to testing, qualification..., working with cross-functional teams and taking the lead from the production department.As the SME, assist in simple manufacturing operations to provide training and guidance as necessaryCollaborate for the continuous improvement of working conditions.Promote and commit to the application of the Company's value system in the decision making of your shift: talent development, fostering teamwork, transparency, flexibility and improvement of team members.

RESPONSIBILITY FOR SAFETY

Ensure manufacturing area safety and work practices in accordance with all company Health, Safety and Environmental programs.

collaborate in the investigation of accidents and incidents and in the development of the prevention program

Ensure the maintenance of the work center in optimal conditions of cleanliness and compliance with established safety and hygiene standards. 

REQUIREMENTS

- This position preferably requires a minimum of 2+ years of experience in the pharmaceutical industry.

- Biosanitary or engineering university studies preferred.

- Oral and written communication skills in English and Spanish.

- Knowledge of pharmaceutical production.

- Ability to adapt and flexibility to change

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.