Specialist II - Mts/Msat

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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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.

Summary of Objective:

The Manufacturing Technical Specialist provides technical (scientific/engineering) knowledge to enable GMP manufacturing, ensure regulatory compliance, inclusive of direct client support. These efforts are directed to support the company's Aseptic and Non-Aseptic manufacturing processes including Pharmaceutical Form/Fill/Finish and Medical Device manufacturing. The incumbent assist with technical transfers by implementing client processes, developing and writing Batch Records as well as Reports for technical studies. The incumbent is also expected to provide Quality system support (own deviations, investigations, excursions, CAPA execution). The incumbent develops, edits and completes additional cGMP documentation (SOP's, material specifications, training) related to manufacturing operations and client specifications. The MTS Specialist II participates and provides input and feedback for the PCI EHS Program to meet Health and Safety regulations and OSHA requirements in all duties.

Essential Duties and Responsibilities:

• Provide technical Support for technical transfer of new processes with minimal supervision.

• Utilize manufacturing and GMP process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations and affect positive change.

• Author Production Batch Record modules and SOPs for new processes, perform revisions/edits for existing records. Conducts complex investigations, document revisions and/or document management including batch production records, manufacturing procedures, and cross functional procedures.

• Assist in specifying materials and components with cross functional teams.

• Work with manufacturing Operations to develop and maintain production records compliance.

• Train manufacturing personnel as needed to support Quality systems and batch documentation.

• Support technical studies to support cGMP process/material implementation as well as for quality system investigations/root cause analysis.

• Perform root cause analysis for investigations, perform risk assessments when required.

• Own and manage assigned manufacturing internal investigations, CAPAs, and supporting Quality documentation.

• Meet and interact with clients, as needed, to complete, discuss, and document client decisions regarding, for example, manufacturing materials and processes related to Batch Records.

• Practices and promotes safe work habits and adheres to PCI's safety procedures and guidelines.

• Perform other duties as required to support PCI GMP Operations activities.

• Works directly with aseptic, non-aseptic, and medical device Operations personnel, and Project Management Leads, Quality Assurance, Validation, EHS, Engineering, Facilities and will directly interface with clients. Knowledge of medical device or pharmaceutical industries (experience with FDA QSR or ISO 13485/medical devices preferred).

• TRAVEL -

Qualifications:

• Three 3+ years of experience in either a technical or manufacturing role or 3+ years of GMP experience in a regulated industry (pharmaceutical, biotech or medical device)

• Knowledge of biopharmaceutical and/or medical product formulation, filtration and filling operations.

• Preferred experience with operation of GMP scale manufacturing equipment

• Familiarity with Quality Deviation Management Systems is a plus.

• Knowledge of Current Good Manufacturing Processes (cGMP), Regulatory Guidelines, Aseptic Manufacturing, as well as bulk intermediate and medical device manufacturing.

• Clean Room (Aseptic) experience a plus.

• Experience in troubleshooting, investigation, and root cause analysis in a GXP environment.

• Bachelor's Degree/Associate degree in life Science or a related field. Comparable blends of experience or education are acceptable.

• Excellent problem solving and analytical skills required.

• Possess skills and techniques for leading and performing Quality System Investigations

• Proficiency with MS Office (Word/Excel/Access/ PowerPoint/One Note).

• Skilled at working with aggressive deadlines while multi-tasking CMO environment and support multiple projects and activities

• Requires excellent organizational and interpersonal skills, team-player.

• Excellent written and oral communication skills are required. Possess strong technical writing skills necessary for composing GMP documentation including master batch records and deviation/investigation management systems or a similar technical writing system

• Creative with the ability to work in a dynamic, fast paced work environment

• Honesty, integrity, respect and courtesy with all colleagues. A team player and contributing collaborator.

• Highly effective working with minimal supervision

• Demonstrates flexibility and adaptability in the work environment

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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.