Engineer I - Manufacturing Science and Technology

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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. At level I, the MTS Specialist receives guidance and direct supervision in the execution of their duties. The Specialist I assists in the technical transfer of client processes, generate batch records and reports for technical studies, and provide Quality System support via the ownership of deviations, CAPAs, change controls, and excursion investigations. The incumbent is also expected to support efforts to develop, edit, and complete additional GMP documentation (e.g., SOPs, material specifications, training documentation) related to manufacturing operations and client specifications. The Manufacturing Technical Specialist is engaged in providing input and feedback for the PCI Safety Program to meet health and safety regulations and OSHA requirements.

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.

• With supervision and guidance, provide technical support to project management and manufacturing operations during the technical transfer of new processes
• Identify and resolve manufacturing issues, improve process operations, and affect positive change
• Write batch record modules and SOPs for new processes; perform revisions/edits for existing documents as directed
• Assist in specifying equipment, materials, and components with cross-functional groups for new processes
• Work with manufacturing operations to develop and maintain production records for safety and compliance
• Assist in resolutions to deviations, generate corrective/preventative actions, (and support Quality documentation for manufacturing processes
• Perform root cause analysis for investigations; perform risk assessments when required
• Meet and interact with clients from the initiation of technical transfer, during the manufacturing process, and following operations, providing technical knowledge and expertise at every stage of the project
• Perform other duties as required to support PCI operations
• Works directly with aseptic, non-aseptic, and medical device Operations personnel and Project Management Leads. Works closely with Quality Assurance, Validation, EHS, Engineering, Facilities and will directly interface with clients

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.

• Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes
• Ability to gown and gain entry to controlled manufacturing areas
• Ability to lift, pull or push equipment requiring up to 25 lbs. of force
• Ability to stand for prolonged periods in a production suite and work extended hours as needed

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.

• Bachelor's or associate degree in life sciences or related discipline with One + years' experience in a technical, quality, or manufacturing role required, 2+ years of GMP experience in a regulated industry (e.g., pharmaceutical, biotech, or medical device) preferred. Comparable blends of education and/or experience is acceptable.
• Knowledge of Current Good Manufacturing Practices (cGMP), regulatory guidelines, aseptic manufacturing, as well as bulk intermediate and medical device manufacturing
• Working knowledge and experience utilizing MS Office (Word/Excel/Access/Visio/PowerPoint)
• Clean room (aseptic) experience a plus
• Preferred experience with operation of GMP scale manufacturing equipment
• Demonstrated proficiency 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 following through on guidance and work assignments
• Flexible and adaptable as the job may require
• Professional skills in biopharmaceutical and/or medical product formulation, filtration, and filling operations preferred
• Possess excellent problem solving and analytical skills
• Skills and knowledge to perform quality system investigations, preferred
• Ability to meet aggressive deadlines while multi-tasking
• Requires excellent organizational and interpersonal skills
• Excellent oral and written communication skills required
• Ability to work with supervision and guidance, coupled with the ability to follow through on direction leading to assignment/project completion
• Travel < 10%

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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.