QC Instrumentation Engineer I

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 QC Instrument Engineer role will focus on support and upkeep of the QC equipment lifecycle. The incumbent in this individual contributor role will coordinate across multi-discipline teams to meet business objectives related to the Quality Control test equipment

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Maintain ownership of QC Testing Instrumentation lifecycle activities, such as asset induction, qualification, move/decommission, validation, CSV activities, etc. and timelines.
• Serve as the point person in QC for all equipment inquiries and relay to appropriate vendors as well as onsite support.
• Support instrument/equipment needs of the QC laboratory including the Microbiology, Analytical, Analytical Development and Sample management teams.
• Manage and own quality systems records such as deviations, investigations, MOCs, CAPAs from start to finish.
• Ensure timely completion of instrument qualification/requalification activities through interactions with Validation and Calibration teams and ensures compliance with internal PCI, global, and regulatory guidelines
• Ensure that QC test equipment is functional, is up to date on maintenance and qualification activities, and available for use by the QC labs. Identify when test equipment is no longer capable and lead the effort to repair or replace.
• Review equipment logbooks, protocols, procedures and use for adherence to local, global and regulatory policies, procedures and guidelines.
• Support efforts for method troubleshooting remediation, change, and optimization efforts in cross functional teams
• Author, update, and maintain Equipment/Instrument SOPs.
• Ensure departmental procedures and policies comply with latest versions of local, global and regulatory policies, procedures and guidelines and participate in revisions as needed
• Identify and scope projects of small and large complexity required to keep equipment and the department in compliance. Lead initiatives and projects for new systems/equipment, ensuring that QC equipment and the department are in cGMP compliance.
• Receive and review revisions to USP, EP, JP, FDA regulatory guidelines in concert with other members of the compliance team. Provide input to the team and participate in change procedures as needed. Assist in the preparation for both internal and external audits.

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

• Demonstrated ability to problem solve, organize, and complete project timelines independently.
• Excellent computer skills including knowledge of equipment data quality systems.
• Advanced knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
• Strong technical background in Microbiology and/or Analytical Instrumentation/Software, Metrology, method acquisition and instrument troubleshooting.
• Strong technical writing skills, oral communication, and organizational skills.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.

• Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment
• Strong presentation development and delivery skills. Ability to lead meetings presenting data in concise and organized fashion
• Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint, and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Minimum bachelor's degree in science related field, engineering, or equivalent
• Minimum 5 years' experience in GMP environment regulated industry.
• Two-three years' experience with troubleshooting complex laboratory equipment.
• Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
• Possess experience with investigations
• Experienced and effective ability to plan and organize assigned tasks in a fast-paced environment, and concurrently monitor tasks / assignments with others that may impact timely completion

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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.