{"id":2284276,"url":"https://alion.io/job/pci-pharma-services-compliance-specialist","title":"Compliance Specialist","company":{"id":1987116,"name":"PCI Pharma Services","domain":"pci.com","url":"https://alion.io/company/pci-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":78,"open_postings":19,"ghost_share":0,"stale_share":0.895,"repost_share":0,"time_to_fill_p50_days":28,"computed_at":"2026-10-25T05:49:26Z"}},"role":"Legal","role_family":"Legal","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bedford, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":41000,"max_usd":102000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":952},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Mandiant capa","optional":false}],"status":"live","first_seen_at":"2026-08-11T00:00:00Z","employer_posted_date":"2026-08-11","last_verified_at":"2026-10-23T02:39:09Z","board_verified":false,"closed_at":null,"days_open":75,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":75},"description":"Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.\nWe are PCI.\nOur 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.\nJOB DESCRIPTION:\nPosition Title: Engineering Compliance Specialist\nLocation: Bedford, New Hampshire\nDepartment: Engineering\nReporting To: Director, Engineering and Maintenance\nResponsible For (Staff): No\nAs the Engineering Compliance Specialist, you will play a pivotal role in ensuring the effective management and implementation of change controls, deviations, CAPA plans, and SOP updates within our sterile fill finish operations. You will collaborate with various departments to drive continuous improvement, maintain regulatory compliance, and enhance overall operational efficiency.\nESSENTIAL DUTIES AND RESPONSIBILITIES:\nChange Control Management:\nInitiate, review, and manage change control documentation related to equipment, processes, and systems.\nFacilitate cross-functional communication to ensure alignment with stakeholders and timely resolution of change requests.\nConduct impact assessments to evaluate the potential effects of proposed changes on product quality, safety, and efficacy.\nDeviation Handling:\nLead investigations into deviations, identifying root causes and implementing corrective and preventive actions.\nCollaborate with Quality Assurance, Manufacturing, and other relevant departments to develop comprehensive deviation reports.\nEnsure timely closure of deviations while maintaining compliance with regulatory requirements.\nCAPA (Corrective and Preventive Action) Planning:\nDevelop and execute robust CAPA plans in response to identified issues or areas for improvement.\nCoordinate with cross-functional teams to implement corrective actions and preventive measures.\nMonitor and track CAPA effectiveness, making adjustments as necessary to enhance long-term performance.\nCommunication and Collaboration:\nAct as a liaison between engineering, quality, manufacturing, and other relevant departments to ensure seamless communication and collaboration.\nProvide regular updates on change control, deviations, and CAPA status to management and relevant stakeholders.\nFoster a culture of proactive problem-solving and continuous improvement\nQUALIFICATIONS:\nRequired:\nEXPERIENCE\n2+ years’ experience with GMP, ISO, and/or an FDA-regulated environment is required.\nStrong technical writer and SME in writing all Quality system documents (CAPAs, Deviations, Change Controls, SOPs, Reports, etc.)\nSME in investigation, root cause, and risk analysis in a cGMP environment for complex issues within the production environment\nStrong understanding of regulatory requirements, and industry best practices\nEDUCATION\nBachelor’s Degree in a Science or Engineering related field preferred\nQUALITIES -\nDetail oriented with strong analytical and problem-solving capabilities\nProject management skills and the ability to drive initiatives to completion\nExcellent communication and interpersonal skills with the ability to work collaboratively across departments\nAssertive, self-directed, and results-oriented\nHonesty, integrity, respect, and courtesy with leadership and peers \nStrong commitment to conducting PCI PHARMA SERVICES business according to the highest legal and ethical standards and to continually pursue excellence in the manufacturing and delivery of PCI PHARMA SERVICES products and services. \nJoin us and be part of building the bridge between life changing therapies and patients. Let’s talk future\nEqual Employment Opportunity (EEO) Statement:\nPCI 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.\nAt 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.","description_format":"text","description_chars":4663,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-11T12:57:54Z"}],"visa":[],"liveness":{"score":7,"band":"cold","label":"Long shot","p_open":0.9,"p_active":0.273,"p_room":0.28,"age_days":75,"expected_fill_days":28,"reasons":["conf:51","stale_co","velocity","win:tail","crowd:junior,brand"],"computed_at":"2026-10-25T05:49:26Z"},"pay":null,"html_url":"https://alion.io/job/pci-pharma-services-compliance-specialist","json_url":"https://alion.io/job/pci-pharma-services-compliance-specialist.json","meta":{"generated_at":"2026-10-25T10:39:26Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":15234,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-26T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1987116},"rest":"https://alion.io/mcp/rest/get_company?id=1987116"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fpci-pharma-services-compliance-specialist"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fpci-pharma-services-compliance-specialist"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fpci-pharma-services-compliance-specialist"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/pci-pharma-services-compliance-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpci-pharma-services-compliance-specialist"}]}