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 is responsible for assisting the manufacturing team in a variety of complex tasks in accordance with the FDA and other regulatory agencies’ expectations while following all safety and quality guidelines of PCI. The Manufacturing Specialist collaborates with the operations department in the execution of production across multiple shifts against department operational goals. This position will be the Subject Matter Expert (SME) within the operations processes and is expected to be highly versed in validation, regulatory, and quality requirements as it pertains to cGMP. As the process operations subject matter expert, the incumbent is expected to lead process improvement initiatives.
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.
Ensure efficient operation of process floor activities by developing/improving processes, materials, GMP, and safety controls.
Collaborate/Assist with the Quality, Operations, Material Management, Engineering, MTS, Validation, Facilities, Finance, and R&D teams to optimize processes, applying Lean principles where applicable.
Organize and analyze large amounts of continuous manufacturing process data for process investigations, troubleshooting, and continuous process improvements requiring advanced data collection and analysis skills
Drive efforts to address regulatory compliance issues related to production.
Work closely with Operations Management to guide staff in alignment with cGMP requirements, department goals, and corporate quality standards.
Proactively identify, evaluates, and mitigate operational and organizational risks; escalate key risks and issues to manufacturing senior management and cross-functional support teams
Ensure manufacturing SOPs and batch records reflect practice and align with cGMPs/ISO and corporate standards.
Author and perform investigations, deviations, CAPAs, CCR, and other GMP documentation and ensure timely completion.
Performing technical review of batch records and supporting data in collaboration with QA and QC for batch release
Ensure work done by enabling/support groups is completed to standards. Participates in/supports regulatory inspections conducted by external auditors, as required.
Identify continuous improvement opportunities to improve processes and practices and make changes in conjunction with supervisors and operators.
Partner with cross-functional groups to evaluate and drive resolution of operational issues and proactively drive continuous improvement projects to completion
Successfully participate in media fill / aseptic proficiency test and maintains qualification if applicable.
Works within defined processes, steps, and methods and will assist in developing procedures for new assignments or tasks.
As the SME, assist in manufacturing operations to provide training and guidance as necessary
As the SME, the Manufacturing Specialist will train potential operations trainers and operators.
Acts as Liaison and SME for new projects, creates processes and appropriate SOPs
Other duties as assigned
PROFESSIONAL SKILLS
Intermediate/advanced PC skills, MS Office, and Microsoft project applications are required
Ability to prioritize and manage multiple resources in a production environment with flexibility to meet organizational needs
Proven leadership, initiative, project management, and problem-solving skills
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
Stationary Position: 3/4 of the day and up.
Move, Traverse: From 1/4 to 1/2 of the day.
Operate, activate, use, prepare, inspect, or place: Up to 1/4 of the day.
Install, place, adjust, apply, measure, use, or signal: None.
Ascend/Descend or Work Atop: Up to 1/4 of the day.
Position self (to) or Move (about or to): From 1/2 to 3/4 of the day.
Communicate or exchange information: 3/4 of the day and up.
Detect, distinguish, or determine: 3/4 of the day and up.
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.
EXPERIENCE
5+ years’ experience with GMP, ISO, and/or an FDA-regulated environment is required.
3+ years of experience in an operations role in a cGMPs/ISO environment. Strong understanding of cGMPs
Strong technical writer and SME in writing all Quality system documents (CAPAs, Deviations, Change Controls, etc.)
SME in troubleshooting, investigation, root cause, and risk analysis in a cGMP environment for complex issues within the production environment
Strong understanding of validation principles and practices to ensure compliance with operations.
EDUCATION
QUALITIES
Detail oriented with strong mechanical aptitude
Sets the example for fostering collaboration and teamwork
Assertive, self-directed, and results-oriented
Honesty, integrity, respect, and courtesy with leadership and peers
Strong commitment to conducting PCI business according to the highest legal and ethical standards and to continually pursue excellence in the manufacturing and delivery of LSNE products and services.
Resilient, can quickly move forward despite challenges, thrives on challenges to improve skills and abilities
Must be able to work as a self-starter and handle multiple priorities in a dynamic cross-functional team-based environment.
#LI-LL1
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.
