Technical Services Associate

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 Technical Services Associate will support licensing submissions and ensure compliance for licenses managed by Technical Services. The role will also support change controls and contribute to the successful implementation of Technical Services projects.

Main Responsibilities:

• To support the introduction of any new process or equipment to PCI in conjunction with business requirements.

  • Assist in validating, testing, and implementing new systems, equipment, and processes to enhance operational efficiency.

  • Collaborate with cross-functional teams to ensure integration of new systems.

  • Document and communicate best practices, SOPs, WIs and training materials for newly introduced equipment and processes.

  • Conduct risk assessments and contribute to change control processes to ensure compliance with company policies and industry regulations.

• To assist and lead technical services projects.

  • Participate in data collection, analysis, and reporting for technical services projects to assess performance and impact.

  • Contribute to problem-solving efforts by identifying root causes of technical issues and proposing practical solutions.

  • Assist in preparing project documentation, including reports and presentations, for internal and external stakeholders.

• To support the licensing and regulatory requirements.

  • Ensure compliance with all regulatory requirements related to controlled drugs, DEFRA and HSE.

  • Assist in preparing and maintaining documentation required for licensing applications, audits, and regulatory submissions.

  • Stay updated on regulatory changes and assist in implementing necessary adjustments to policies and procedures.

  • Support audits and inspections by regulatory bodies, providing necessary technical data and documentation.

• To provide technical assistance to Director, Technical Services as required.

• Help in identifying and implementing continuous improvement opportunities within technical services.

• Assist with new and ongoing validations as required. Support troubleshooting and resolution of issues arising during validation activities.

Specific Qualifications:

• Attained or working towards Six Sigma Green Belt.

• Knowledge of regulatory requirements including GMP, GDP, DEFRA, HSE, and controlled drug regulations.

Previous Work Experience:

• Experience in a similar role at a senior level within a pharma/healthcare company.

• Strategy development and business plan implementation.

Specific Knowledge / Skills Competence:

• Experience in the clinical supply field, preferably in a contract environment

• Broad knowledge of JDE or similar enterprise management systems

• Awareness of GMP documentation.

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.