Technical Engineer I, Validations

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Summary of Objective:

Technical Engineer I - Validation is responsible for executing engineering and technical protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), in accordance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and company policies. This role may include working through technical issues, problem solving, and risk mitigation activities associated with New Product Introduction, deviations, complaints, or nonconformances. This role may involve protocol development under supervision, but will focus on the accurate, consistent, and compliant execution and documentation of predefined validation activities.

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 are the following but other duties may be assigned.

Execute validation protocols (IQ, OQ, PQ, and other test scripts) and engineering studies as assigned, ensuring compliance with regulatory and internal quality standards.

Document all test results accurately and legibly in accordance with GDP.

Report deviations or non-conformances during execution promptly and assist in root cause analysis and corrective action implementation.

Set up and operate equipment per validation protocol instructions and safety procedures.

Collaborate with Validation Engineering, Project Engineering, Quality Engineering, Quality Assurance, and Manufacturing teams to coordinate execution schedules.

Maintain and manage protocol documentation and ensure that all required test documentation is completed and reviewed in a timely manner.

Performs investigations - participates in investigation to determine root-cause for low to moderate complexity issues.

Support the creation and review of Quality Engineering deliverables and Process Validation deliverables.

Support and/or drive a process or technology improvement globally or at the site level.

Ensure that technical information is accurate and in compliance with quality or regulatory requirements.

Complete change documentation to include technical rationale and formal verification test results.

Utilize appropriate experimental, statistical and engineering tools.

Participate in walkthroughs and audits as needed to support regulatory and internal compliance inspections.

Demonstrate teamwork skills Collaborates across functional areas - exchanges information with project team members, engineers, business unit representatives and other production personnel.

This position may require extended travel, overtime, and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

Attendance at work is an essential function of this position.

Performs other duties as assigned by Manager/Supervisor.

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

Required:

• Bachelor of Science in a Technical Discipline

• 0-3 years of experience in GMP-Regulated environment, preferably pharmaceuticals or medical devices.
• Experience or familiarity with developing and executing technical studies/protocol
• Experience in working in a quality/technical role/environment.

Preferred:

• Ability to demonstrate attention to detail.
• Working knowledge of validation concepts (IQ/OQ/PQ).
• Strong documentation and GDP skills.
• Ability to interpret mechanical drawings, equipment schematics, and user manuals.
• Ability to read and follow instructions, SOPs, and protocols.
• Ability to work independently and in a team environment.
• Good communication skills and time management.

The hiring rate for this position is $62,960-$70,830 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.

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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.